Pseudoephedrine Research Articles

Novel Green Chromatographic Approaches for Estimation of a Triple Common Cold Pharmaceutical Combination.

Nowadays, there is a strong interest in the scientific community in developing innovative methodologies within a green analytical chemistry framework. Herein, we introduce the first chromatographic approaches for the concurrent estimation of paracetamol (PAR), carbinoxamine (CRX), and pseudoephedrine (PSE) intended to relieve COVID-19 and common cold symptoms. The first method was thin layer chromatography (TLC) densitometry, which depends on the separation of the studied medications on TLC silica gel plates using ethyl acetate: methanol: ammonia (7.0: 3.0: 0.2, by volume) as the developing system, and were scanned at 208.0nm. The data were linear in the ranges of 1-25μg/band for PAR, 1-25μg/band for PSE and 0.1-5μg/band for CRX. The second method was reversed-phase high-performance liquid chromatography separation on a Kromasil C18 column using a mixture of 0.01M phosphate buffer containing 0.1% triethylamine (pH3.5) adjusted with orthophosphoric acid and ethanol at a flow rate of 1.0 mL/min in a gradient program. The separated peaks were detected at 215.0 nm over a concentration range of 10-250μg/mL for PAR, 5-35μg/mL for PSE, and 0.5-25μg/mL for CRX. Both approaches were validated according to International Conference on Harmonization (ICH) guidelines. Finally, the impact of these methods on the environment was evaluated by many tools.

Pseudoephedrine for ejaculatory dysfunction after retroperitoneal lymph node dissection in testicular cancer.

To assess the impact of ejaculatory dysfunction (EjD; failure of emission or retrograde ejaculation) on health-related quality of life (HRQoL) after retroperitoneal lymph node dissection (RPLND) for testicular cancer and explore the efficacy of pseudoephedrine hydrochloride as treatment. In a single arm, phase II trial, patients at ≥6 months after RPLND were invited to complete patient-reported outcome measures (European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaire [QLQ]-30-item core, EORTC QLQ-testicular cancer-26, and Brief Male Sexual Function Inventory) evaluating HRQoL and sexual function in follow-up (ACTRN12622000537752/12622000542796). If EjD was reported, post-ejaculatory urine ± semen analysis was undertaken. In eligible patients, pseudoephedrine hydrochloride 60 mg was administered orally every 6 h for six doses. The primary endpoint was sperm count >39 million sperm/ejaculate (>5th centile) following treatment. The trial was powered to detect a clinically relevant 36% achieving sperm count of >39 million sperm/ejaculate. Secondary endpoints included semen volume >1.5 mL, total motile sperm count, safety, and HRQoL impacts. Of the 58 patients enrolled, the median (interquartile range [IQR]) age was 35 (29-41) years, with a median (IQR) of 37 (18-60) months from RPLND. EjD was reported in 33 (57%), including 27/52 (52%) receiving follow-up at our centre. There were no differences in global HRQoL; however, role functioning (P = 0.045), sexual problems (P < 0.005), and sexual enjoyment (P = 0.005) was poorer if EjD was present. In all, 24/33 (73%) patients with EjD consented to pseudoephedrine treatment. Of 22 evaluable patients, four (18%) achieved a sperm count of >39 million/ejaculate (P = 0.20), and four (18%) had a semen volume of >1.5 mL (P = 0.20). There was a mean increase of 105 million sperm/ejaculate (P = 0.051) and 1.47 mL increase in semen volume (P = 0.01). No safety concerns arose. Ejaculatory dysfunction is common after RPLND but did not impact global HRQoL in our cohort. Pseudoephedrine improved EjD for some; however, its efficacy was lower than expected. Pseudoephedrine may be considered on an individualised basis.

Smart Chemometric‑Assisted Spectrophotometric Approaches for Simultaneous Quantification of Tertiary Combination Recommended for COVID-19 Supportive Treatments with Their Greenness Assessment.

There is an increasing interest of scientific community in developing innovative methodologies for their analysis needs within green analytical chemistry framework. UV spectrophotometry is one of the most promising eco-friendly methods, which is integrated with advanced chemometric tools to enhance the selectivity of the analysis of complex mixtures with severe overlapped signals. Simultaneous determination of a triple-combination of pseudoephedrine hydrochloride (PSE), carbinoxamine maleate (CRX), and paracetamol (PAR) using an artificial intelligence system and multivariate calibration methods. This combination is recently recommended for COVID-19 home-treated patients as part of a symptomatic treatment. Namely, the suggested models are: Artificial Neural Networks, Partial Least Squares, and Principal Component Regression. The proposed algorithms were optimized and developed with the aid of a five-level, three-factor experimental design. The investigated methods were applied over the concentration range of 100-180 μg/mL, 18-16 μg/mL, and 4-12 μg/mL for PSE, CRX, and PAR, respectively. The models validation results demonstrated excellent recoveries (around 98 to 102%), signaling the approaches outstanding resolution capacity for the cited compounds in the presence of common excipients. The outcomes of the studied methods were statistically compared to the official approaches, and no significant difference was found. The suggested models were efficiently employed to determine the selected drugs in their combined tablets without any initial separation steps. The impact of these methods on the environment was evaluated via greenness tools, namely; National Environmental Method Index, Raynie and Driver's green assessment method, analytical Eco-Scale, Green Analytical Procedure Index, and Analytical Greenness Metric. Green chemometric quality assessment of PSE, CRX, and PAR in their pure and pharmaceutical dosage forms. The established approaches are innovative, sustainable, smart, fast, selective, and cost-effective. These models are potential green nominees for routine analysis of the investigated mixture in quality control laboratories.

Two green UV-spectrophotometric techniques applying successive and progressive resolution with new concepts for simultaneous determination of completely overlapping ternary mixture

A spectrophotometric platform based on two smart techniques namely Double Divisor ratio difference spectra spectrophotometry (DDRD) and Derivative ratio amplitude difference method (DR-AD) was applied and validated. These techniques were used for determining and resolving the overlapped spectra of the 3 drugs paracetamol (PAR), pseudoephedrine (PSE) and pholcodine (PHO) in their ternary mixture. DDRD is a successive technique while DR-AD is a progressive one. In DDRD, the mixtures’ spectrum underwent division by a double divisor, and then the ratio difference method was applied. For DR-AD, consequent steps were performed to resolve each drug stepwise. DR-AD technique included division using a single divisor. The linearity ranges encompassed 5-25, 100-800 and 5-50 µg/mL for PAR, PSE and PHO, respectively. These methods were conducted according to ICH guidelines to ascertain accuracy, precision, and specificity. The analysis involved varied concentrations of drug mixtures and a pharmaceutical product. Statistical evaluation revealed no notable distinction between the suggested methodologies and those previously documented. Additionally, adherence to green analytical chemistry principles was demonstrated, establishing them as environmentally friendly analytical approaches.

Pharmacokinetic Analysis of Two N-Substituted Rosmarinic Acid Analogs in Rat Plasma by Liquid Chromatography-Tandem Mass Spectrometry.

This study reports the development of an effective high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method for the quantification of two analogs of rosmarinic acid (RA) in rat plasma, namely methyl (E)-2-(3-(3,4-difluorophenyl)acrylamido)-3-(3,4-dihydroxyphenyl)propanoate (A11) and methyl (E)-3-(3,4-dihydroxyphenyl)-2-(3-(3,4-dihydroxyphenyl)acrylamido)propanoate (A2). These analogs, featuring N atoms instead of O atoms, exhibit enhanced bioavailability and distinct pharmacological activities compared with RA. The HPLC separation was carried out on a C18 column (1.9μm, 2.1mm × 100mm) coupled with a security guard C18 column (5μm, 2.1mm × 10mm). A triple-quadrupole mass spectrometer equipped with an electrospray ionization ion source was utilized for ion generation. Pseudoephedrine hydrochloride was utilized as a standard, and a single-step protein precipitation method using isopropanol:ethyl acetate (v/v, 20:80) was employed for sample pretreatment. The developed method demonstrated excellent linearity over the concentration range of 5-750ng/ml for both A11 and A2, with relative standard deviations of <15% and relative errors within 15% during daily course analysis. The method allowed for the unambiguous quantification and identification of A11 and A2 in vivo. The results of this study provide a meaningful foundation for evaluating the clinical applications of these analogs.

Update on the efficiency and safety of orally administered nasal decongestants

Nasal congestion leading to obstruction is one of the main symptoms in acute rhinosinusitis (common cold), other upper respiratory infections and allergic rhinitis. The EPOS 2020 guidelines place oral decongestants as an efficient therapy for the relief of nasal obstruction. In Romania, there are more than 50 available nasal decongestants, so it is very important for practitioners from all medical domains to be aware of recent data regarding their effectiveness and safety profile. Recent concerns raised by both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding the efficacy and safety of pseudoephedrine (PSE) and phenylephrine (PHE) emphasize the need for informed decision-making in prescribing. Notably, there were concerns raised about the association between PSE, reversible cerebral vasoconstriction syndrome (RCVS) and posterior reversible encephalopathy syndrome (PRES). EMA’s safety committee, Pharmacovigilance Risk Assessment Committee (PRAC), recently recommended measures to minimize risks of serious side effects when using medicines containing PSE. PRAC recommends that medicines containing PSE should not be used in patients with severe or uncontrolled hypertension and severe acute or chronic kidney disease or failure. Additionally, PRAC recommends healthcare professionals to counsel patients to discontinue the use of such medicines promptly and seek medical assistance if they experience symptoms suggesting PRES or RCVS, such as sudden onset of severe headache, confusion, vomiting, visual disturbances or seizures. While effectiveness of oral PSE is confirmed by clinical studies, expert consensus is unfavorable to PHE. Both in vitro and in vivo clinical pharmacology data indicate that neither the recommended doses nor higher doses of oral PHE demonstrate efficacy in alleviating symptoms of nasal congestion.

Simultaneous determination of chlorpheniramine maleate, dextromethorphan hydrobromide and pseudoephedrine HCl in syrup pharmaceutical form using RP-HPLC

A new simple and precise HPLC method has been developed for the estimation of chlorpheniramine maleate, dextromethorphan hydrobromide and pseudoephedrine hydrochloride in syrup pharmaceutical form. The separation of the mixture has been achieved in a short time. Chromatographic separation has been done on Chromegabond WR C18 column 5 μm 120 A 30 cm * 3.9 mm as stationary phase. The mobile phase was contained a 2 gm of sodium perchlorate in mixture of (200 mL acetonitrile + 500 mL methanol + 300 mL Water+ 2 ml triethylamine with a flow rate 1.5 ml/min. The PDA detection is 262 nm and the injection volume was 20 µl. The method has been validated for linearity with great correlation coefficients, accuracy recovery was 98.0-102., and precision with RSD less than 2.0%. This method was successfully used to separate and estimate these drugs purchased from Iraq. The analyzed syrup contains three active ingredients (chlorpheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride) within 100 ±2 % of stated amount of the active ingredients. Validation of this method has been done and this method can be used for determination of these drugs in syrup pharmaceutical form.

Study on Separation Mechanism of Ephedrine and Pseudoephedrine in Borax Buffer by Capillary Electrophoresis

Background: In borax buffer, ephedrine (EPH) and pseudoephedrine (PSE) can be well separated (Rs&gt;10) in capillary electrophoresis (CE) without adding any other compounds, but the specific mechanism remains unclear. Methods: Titration analysis, nuclear magnetic resonance analysis, mass spectrum analysis and molecular modeling were used to investigate the separation mechanism. Results: Tetrahydroxy borate (a hydrolyzate of borax or boric acid) could react with ephedrine and pseudoephedrine to form self-assembled complexes, but the two complexes had different stabilities and electrophoretic mobilities resulting from the different steric configurations of analytes. Conclusion: The complexation based on borax was responsible for the separation.

Determination of rosmarinic acid and its N-substituted analog A1 in rat plasma using high-performance liquid chromatography-tandem mass spectrometry and its application in pharmacokinetics.

The aim of this study was to determine the concentration of rosmarinic acid (RA) and its analog (E)-3-(3,4-dihydroxyphenyl)-2-(3-(3,4-dihydroxyphenyl)acrylamido)propanoic acid (A1) in rat plasma following oral administration. The significance of this study lies in the development of a rapid, sensitive, and alternative method using liquid chromatography-tandem mass spectrometry for the accurate quantification and identification of RA and A1 in vivo. Liquid chromatography-tandem mass spectrometry was employed to analyze RA and A1 in rat plasma. A C18 column (1.9 µm, 2.1 × 100 mm) with a C18 guard column (5 µm, 2.1 × 10 mm) and a triple-quadrupole mass spectrometer combined with an electrospray ionization source were utilized. Sample pretreatment involved a one-step protein precipitation using isopropanol:ethyl acetate (20:80, v/v) as the solvent. Pseudoephedrine hydrochloride served as a standard. The developed method exhibited a linear relationship within the concentration ranges of 5-750 ng/ml for both RA and A1. Relative standard deviations in daily courses were less than 15%, and the relative errors recorded were within 15%. This is the first study to concentrate on determining A1 and RA in rat plasma through oral administration. The liquid chromatography-tandem mass spectrometry method developed in this study offers a rapid, sensitive, and alternative approach for the accurate quantification and identification of RA and A1 in vivo. The findings serve as a significant foundation for evaluating the clinical applications of the medicine.

Effects of pseudoephedrine on rat fetal bone development: evaluation by three different methods.

Pseudoephedrine (PSE) is an agent that is contained in common cold medications. The agent, which is used to treat cold and cough, is the fourth most prescribed drug group in some countries. During pregnancy, expectant mothers use PSE for colds and other reasons. One out of every four expectant mothers use PSE alone or in combination with other medicines for various reasons. This study was aimed to investigate effects of PSE on long bones development in rat during fetal growth. Pregnant rats were divided into five groups: control and four experimental groups (25mg/kg, 50mg/kg, 100mg/kg, 200mg/kg PSE). Between 1 and 20days of pregnancy, PSE was given to them by gavage. Weights and heights of fetuses isolated by cesarean on the 21st day were measured. Ossification of femur and humerus was examined by three different methods mentioned earlier. Depending on the dose increase, all morphometric data, ossification rate and bone length of the fetuses were decreased. Besides, it was determined that the amount of Calcium in the bone tissue decreased in the analyzes made with SEM-EDX Analysis. The data obtained from this study reveal that the use of PSE during pregnancy disrupts the existing balance in the bone and negatively affects ossification due to the dose increase. In conclusion, we present descriptive and novel data on the effects of PSE use during pregnancy on the bone development of rat fetal long bones.

Ephedrae herba: A comprehensive review of its traditional uses, phytochemistry, pharmacology, and toxicology.

Ephedrae herba (called Mahuang in China) is the dried herbaceous stem of Ephedra sinica Stapf, Ephedra intermedia Schrenk et C. A. Mey., and Ephedra equisetina Bge. Ephedrae herba has a long history of use as an herb, and it was originally recorded in Sheng Nong's herbal classic. Ephedrae herba has also been widely used as both medicine and food. In the clinic, Ephedrae herba is commonly used for treating colds, bronchial asthma, nasal congestion, and other diseases. This review aims to provide a systematic summary on the traditional use, chemical constituents, pharmacological effects, clinical applications, quality control, toxicology, and pharmacokinetics of Ephedrae herba to provide a theoretical basis for further reasonable development of Ephedrae herba in clinical practice and creation of new drugs. Information on Ephedrae herba was gathered from various sources, including the scientific databases including CNKI, PubMed, SciFinder and ScienceDirect, classical books on traditional Chinese herbal medicine, Ph.D. and M.Sc. dissertations; Baidu Scholar; and from different professional websites. Ephedrae herba is distributed in regions of China and other areas. Ephedra and its compound preparations can be used for colds, bronchial asthma, nasal congestion and other diseases. Approximately 281 chemical constituents have been isolated from Ephedrae herba, including alkaloids, flavonoids, tannins, polysaccharides, volatile oils, organic acids, and other compounds. Among these constituents, alkaloids and volatile oils are the most abundant and represent the major bioactive constituents. Ephedrae herba possesses multiple pharmacological activities, including diuretic effect, anti-allergic effect, blood pressure regulatory, anti-inflammatory effect, anti-oxidation effect and anti-viral effects. Ephedrine hydrochloride and pseudoephedrine hydrochloride are generally selected as indicators for the quantitative determination of Ephedrae herba. The maximum dosage of Ephedrae herba should not exceed 10 grams. If overused, adverse reactions such as palpitations, sweating, irritability and insomnia will occur. Ephedrae herba is an ancient herbal medicine with a broad spectrum of pharmacological activities that has been used for thousands of years in China. It is one of the most commonly used herbal components of the TCM formulas. Hydrochloride and pseudoephedrine are the major bioactive constituents. However, there is a need to further understand the mechanisms of active components of Ephedrae herba. Future studies should perform an in-depth analyses of the pharmacokinetics and mechanisms of toxicity of Ephedrae herba. Quality standards should be developed to correspond to the various application methods to ensure the efficacy of drugs in actual treatment.

Ephedramine therapeutic effectiveness for allergic rhinitis treatment: a double blind placebo controlled trial

Background : Allergic rhinitis is a common allergic disease worldwide. To date therewas no curable treatment. Study design: Double blind placebo controlled clinicaltrial. Patients and Methods: Ephedramine was evaluated as treatment for allergicrhinitis. One hundred and twenty subjects were included in the study. The patientswas divided into two groups (A) and (B), given either placebo or ephedramine(acombination of pseudoephedrine HCl 60mg plus chlorpheneramine maleate 2.5mg). The drug was given twice daily for subsequent four weeks. Patients withallergic rhinitis and associated conditions were involved in the study. Results: Ourpatients demonstrate a very well response to ephedramine; 44.8% had completeremission from congestion at the end of trial while 78.8% had remission fromRhinorrhoea, 71.1% remitted from sneezing and 80.4% had complete remission frompruritus. The corresponding values in placebo group were 31.5%, 31.5%, 17.8% and31.4% respectively. Side effects of ephedramine include headache (32.7%), dizziness(27.7%), and dry mouth (21.8%). The same above side effects were reported inplacebo group, but with lower frequency. Conclusion: Ephedramine was effective astreatment for allergic rhinitis and associated conditions with non significant sideeffects and minimized antihistamine effect of chlorpheneramine maleate by -adrenergic effect of pseudoephedrine.

Predicting the comprehensive geospatial pattern of two ephedrine-type alkaloids for Ephedra sinica in Inner Mongolia.

Ephedra sinica Stapf. is a shrubby plant widely used in traditional Chinese medicine due to its high level of medicinal value, thus, it is in high demand. Ephedrine (E) and pseudoephedrine (PE) are key medicinal components and quality indicators for E. sinica. These two ephedrine-type alkaloids are basic elements that exert the medicinal effect of E. sinica. Recently, indiscriminate destruction and grassland desertification have caused the quantity and quality of these pharmacological plants to degenerate. Predicting potentially suitable habitat for high-quality E. sinica is essential for its future conservation and domestication. In this study, MaxEnt software was utilized to map suitable habitats for E. sinica in Inner Mongolia based on occurrence data and a set of variables related to climate, soil, topography and human impact. The model parametrization was optimized by evaluating alternative combinations of feature classes and values of the regularization multiplier. Second, a geospatial quality model was fitted to relate E and PE contents to the same environmental variables and to predict their spatial patterns across the study area. Outputs from the two models were finally coupled to map areas predicted to have both suitable conditions for E. sinica and high alkaloid content. Our results indicate that E. sinica with high-quality E content was mainly distributed in the Horqin, Ulan Butong and Wulanchabu grasslands. E. sinica with high-quality PE content was primarily found in the Ordos, Wulanchabu and Ulan Butong grasslands. This study provides scientific information for the protection and sustainable utilization of E. sinica. It can also help to control and prevent desertification in Inner Mongolia.

The simultaneous measurement of quaternary mixture in over-the-counter cold medications using sequential spectrophotometric resolution approach enhanced with in-lab sample enrichment

A sequential spectrophotometric resolution technique (SSRT) was developed in this study without the use of systematic separation procedures to determine drug of a quaternary combination; caffeine (CAF), pseudoephedrine (PSE), doxylamine succinate (DOX), and paracetamol (PAR). Their presence in a tablet with a gap ratio of 3:3:1:150, respectively, and their overlapping spectra with low absorptivities make their resolution and determination impossible without prior separation. successive ratio subtraction technique (SRST) and constant multiplication method were used to solve these problems. Furthermore, an in-lab sample enrichment technique was applied to increase minor components concentration and consequently their absorbanses (CAF, PSE, and DOX). The D0 absorption spectra were generated by successive ratios followed by subtraction and multiplication of the constants. The maximum absorbances of the drugs tested, namely (CAF, PSE, DOX and PAR) were measured at wavelengths of 272.0, 257.0, 260.0, and 248.0 nm, respectively. The limits of detection (LOD) and limits of quantification (LOQ) were 0.021, 0.124, 0.186, 0.137 and 0.070, 0.414, 0.621, 0.456 (µg/mL), respectively. The linearitiy ranges (µg/mL) were 1.0–22.0, 1.0–24.0, 10.0–90.0 and 1.0–15.0 for CAF, PSE, DOX, and PAR, respectively. The International Conference on Harmonization (ICH) guidelines were applied for method validation, and the results obtained were within the limited parameters. The finding results were compared to official and/or published analytical methods to determine the procedure's reliability. It was noted that there was no actual difference in accuracy and precision between both meyhods. The proposed technique is sensitive, selective and economic;so it can be applied to the simultaneous analysis of these drugs in their commercial tablets and/or in quality-control laboratories.

Comparison of ephedrine and pseudoephedrine contents in 34 Kampo extracts containing Ephedrae Herba used clinically in Japan.

Ephedrae Herba is among the important crude drugs prescribed in Kampo medicine for the treatment of cold, flue, rhinitis, nasal congestion, cough, and asthma. The active ingredients of Ephedrae Herba, ephedrine (E) and pseudoephedrine (PE), are potent sympathomimetic compounds that stimulate α-, β1-, and β2-adrenoceptors resulting in dilatation and alleviation of nasal mucosal hyperemia. Hypertension, palpitations, insomnia, and dysuria are the main adverse effects of E and PE, which can be avoided by determining the actual contents of these alkaloids in Kampo extracts containing Ephedrae Herba. However, the extraction efficiencies of E and PE from Ephedrae Herba contained in Kampo formulas in combination with other crude drugs remain unknown. Therefore, we comprehensively determined the E and PE contents of 34 Kampo extracts containing Ephedrae Herba used clinically in Japan. The E and PE contents per daily dosage in Kampo extracts were generally proportional to the compounding amount of Ephedrae Herba. In contrast, the extraction efficiencies of E or PE were not constant and not influenced by the pH of the extracts. We assume that the extraction efficiencies of E and PE may be independently affected by other constituent crude drugs. Thus, it is necessary to investigate the cause and mechanism in the future. In conclusion, these results show that the E and PE content of each Kampo formulation can be estimated from the compounding amount of Ephedrae Herba. Therefore, the amount of Ephedrae Herba should be carefully considered to ensure the safe use of Kampo formulations containing Ephedrae Herba.

Trial in progress: PREPARE—Exploring the activity of pseudoephedrine in treating retrograde ejaculation following retroperitoneal lymph node dissection (RPLND) in survivors of testicular cancer (TC).

TPS432 Background: Retrograde ejaculation is a known complication of RPLND occurring due to interruption of sympathetic nerve fibres intraoperatively. Whilst common immediately after surgery, the prevalence of persistent symptoms, and impact on health-related quality-of-life (HRQoL) in TC survivors is unknown. Whilst few effective treatments are available, alpha-sympathomimetics such as pseudoephedrine may form a viable treatment option due to effects on bladder neck constriction at sexual climax propagating antegrade ejaculation. Existing studies have shown pseudoephedrine may be helpful in individuals with retrograde ejaculation; however, these studies have only included a small number (n=5) of patients following RPLND. Methods: In a two-part, single-arm phase 2 clinical trial, participants with a history of TC receiving follow-up after RPLND at least &gt;6 months prior will be invited to participate. In part A (ACTRN12622000537752), eligible participants complete questionnaires regarding survivorship issues including sexual function and fertility to explore the prevalence of retrograde ejaculation and HRQoL. Questionnaires include EORTC QLQ-C30, sexual function items from EORTC QLQ-TC26, Brief Male Sexual Function Inventory and tailored questions focusing on retrograde ejaculation. 15 out of a planned 50 participants (30%) have been enrolled and completed questionnaires. If retrograde ejaculation is reported, eligible participants are invited to enrol in Part B (ACTRN12622000542796), where if the participant has no contraindications to pseudoephedrine, nor are they receiving testosterone replacement and retrograde ejaculation is confirmed during screening, they receive a short course of pseudoephedrine hydrochloride. Pseudoephedrine will be given 60mg QID for one-day, followed by 60mg 4 hours and 1 hour prior to ejaculation to evaluate changes in ejaculation volume, sperm count within (any) antegrade ejaculate and within the post-ejaculatory urine. The primary endpoint is total sperm count in antegrade ejaculate of at least 39 million (5th centile) following treatment. We assumed that pseudoephedrine is ineffective if &lt;10% of participants achieve a normal sperm count in antegrade ejaculate after treatment. Using an exact binomial power analysis for a one-sample proportion test, a sample size of 25 participants provides &gt;80% power to detect 36% (9 out of 25) of participants achieving a normal sperm count against a reference proportion of 10% at the 0.05 significance level. 4 out of a planned 30 participants (16%) have been enrolled. All participants with retrograde ejaculation will be invited to an optional, semi-structured interview to further evaluate impact(s) of retrograde ejaculation on issues around sexual health, relationships, body image and masculinity. Clinical trial information: ACTRN12622000537752 , ACTRN12622000542796 .

Evaluation of rooting characteristics of Ephedra cuttings by anatomy and promising strain selection based on rooting characteristics and alkaloid content

The differences in rooting characteristics of cuttings prepared from E. sinica strains were investigated and found that cuttings prepared from strains with high rooting characteristics showed approximately 90% of the cuttings were rooted, whereas cuttings prepared from low rooting characteristics did not root. To understand the reason for this substantial difference, the anatomy of nodes was examined and found that adventitious roots were generated from the cortex and parenchyma in pith. Calculations of the correlation coefficients between the rooting rate and the value of anatomy indicated that the rooting rate was positively correlated with the parenchyma in pith in the node. On the basis of the positive correlation, it is possible to estimate the rooting characteristics of new strains without having to prepare cuttings. Next, we conducted a screening for E. sinica strains on the basis of total alkaloids content [ephedrine (E) + pseudoephedrine (PE)] and selected strains having no less than 0.7% total alkaloids content as defined by the Japanese Pharmacopoeia 18th edition. Strains having characteristic E or PE content were uncovered: E-rich strains had 100% E content and PE-rich strains had 99% PE content. We were able to select E. sinica strains on the basis of two factors: high rooting rate of cuttings and high or characteristic alkaloid content. These strains are valuable for breeding.

DETERMINATION OF PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE SIMULTANEOUSLY BY USING AREA UNDER CURVE SPECTROPHOTOMETRY ULTRAVIOLET

Anti-influenza drugs on the market contain a combination of more than one active substance in one preparation. An example is pseudoephedrine hydrochloride and triprolidine hydrochloride in tablet form. The goal of this research is to determine pseudoephedrine hydrochloride and triprolidine hydrochloride simultaneously by using the area under curve spectrophotometry. The area under the curve in the wavelength range of 306.6-316.6 nm and 253.6-263.6 nm were selected to determine pseudoephedrine hydrochloride and triprolidine hydrochloride, respectively. The method was linear at a concentration range of 180-500 μg/mL (correlation coefficient 0,9994) and 6-18 μg/mL (correlation coefficient 0,9996) for the pseudoephedrine hydrochloride and triprolidine hydrochloride, respectively. The mean % recoveries for pseudoephedrine hydrochloride and triprolidine hydrochloride were 100.01% and 100.07%, respectively. This method was successfully used to determine pseudoephedrine hydrochloride and triprolidine hydrochloride simultaneously.

Simultaneous determination of chlorpheniramine maleate, pseudoephedrine hydrochloride, oxolamine citrate and paracetamol by HPLC-PDA in pharmaceutical dosage forms

Simultaneous determination of chlorpheniramine maleate, pseudoephedrine hydrochloride, oxolamine citrate and paracetamol by HPLC-PDA in pharmaceutical dosage forms

Application of green first derivative synchronous spectrofluorometric method for quantitative analysis of fexofenadine hydrochloride and pseudoephedrine hydrochloride in pharmaceutical preparation and spiked human plasma

Fexofenadine hydrochloride and pseudoephedrine hydrochloride are prescribed in a combined dosage form for the treatment of allergic rhinitis. In the present work, a sensitive synchronous fluorescence spectroscopic method was applied in conjunction with first derivative for quantitative estimation of fexofenadine hydrochloride and pseudoephedrine hydrochloride in pure form, pharmaceutical tablets and spiked human plasma. Fexofenadine hydrochloride showed its conventional emission spectrum at 294 nm when excited at 267 nm. On the other hand, pseudoephedrine hydrochloride showed its conventional emission spectra at 286 nm when excited at 261 nm. The fluorescence intensities were greatly enhanced by the use of sodium dodecyl sulphate as a micellar surfactant. Application of the synchronous mode to measure the fluorescence spectra of the above drugs provided sharp narrowing bands, but the overlap was not completely resolved. Derivatization of the synchronous spectra to the first order completely resolved the overlap of the fluorescence spectra and allowed simultaneous quantitative determination of the drugs under study. Fexofenadine hydrochloride and pseudoephedrine hydrochloride could be determined from their first-order synchronous spectra at 286 and 294 nm, respectively, without interfering with each other. The method showed linearity with an excellent correlation coefficient in the concentration range of 100–1500 ng/mL for Fexofenadine hydrochloride and 50–1000 ng/mL for pseudoephedrine hydrochloride. The method was successfully applied for the simultaneous determination of the studied drugs in pharmaceutical formulation, with mean percent recoveries for Fexofenadine hydrochloride and pseudoephedrine hydrochloride of 99.49 ± 0.931 and 98.67 ± 0.634, respectively, and in spiked human plasma, with mean percent recoveries for Fexofenadine hydrochloride and pseudoephedrine hydrochloride of 95.21 ± 1.938 and 94.89 ± 1.763, respectively. Furthermore, the greenness of the described method was assessed using four different tools namely, the national environmental method index, the analytical eco-scale, the green analytical procedure index and the AGREE evaluation method. The proposed method seemed to be superior to the reported HPLC method with respect to the metrics of the greenness characters.