Label Claim Research Articles

Physicochemical and In-Vitro Bioequivalence Analysis of Some Oral Solid-Dosage Metronidazole Formulations

Background: Metronidazole is a 5-nitroimidazole antimicrobial agent, widely used in the treatment of infections caused by Trichomonas vaginalis, such as trichomoniasis, pseudomembranous colitis, and symptomatic amoebiasis resulting from anaerobic bacteria. Aim: The study aimed to qualitatively determine the quality and in-vitrobioequivalence of selected brands of metronidazole tablet dosage forms used in the management of infectious diseases. Method: The British Pharmacopeia (BP) Standard methods were followed to conduct weight uniformity, disintegration time, hardness, and friability tests. For the Thin Layer Chromatographic (TLC) Fingerprinting, 0.1g of the brands were weighed and dissolved ins 50 ml methanol (50%). The stock solution was prepared using 50% methanol and 50% dichloromethane and was transferred into the Chamber and allowed to stand for about 45 minutes; the plates were viewed under UV-VIS Spectrophotometer at 365 nm. Result: All the brands complied with the acceptable friability limit, and disintegrated within the appropriate time of not more than 15 minutes as specified in BP, for uncoated tablets. The tablets were found to have a dissolution profile of at least 70% of the active ingredient taken at 45 minutes from the dissolution medium as stated in BP. The analysis showed the consistency of concentration of the selected tablet brands with the label claims. Conclusion: The TLC procedure used in the analysis was accurate and precise, no interference was observed from the excipients. Thus, this method can be used in the routine quality control of metronidazole solid dosage form.

A COMPARATIVE QUALITY STUDY OF SELECTED AUTHORIZED AND SMUGGLED MEDICINES IN ADEN, YEMEN

In Yemen, most of the medicines are imported. Drugs that enter the country by legal means undergo some tests by Supreme Board for Drugs and Medical Appliances (SBDMA) to evaluate the quality of the product. However, some medicines enter the country illegally (smuggling) and this makes them bypass the evaluation of their quality by the SBDMA. This work was carried out to determine the physical quality control parameters of authorized and smuggled drug products marketed in Aden pharmacies. The authorized and smuggled brands of cefuroxime (CEF), atorvastatin (ATR), and carvedilol (CAR) tablets available in Aden pharmacies were selected. The tablets were evaluated for their physical properties and quality control parameters including weight variation, hardness, friability, and disintegration test. The level of drug content also was evaluated using UV spectroscopy. The physical assessment showed that the authorized and smuggled brands of the same products were uniform in shape, color, packing, and labeling information except for the registration number and manufacture date which were present only on the authorized brands. The three authorized and smuggled brands of CEF, ATR, and CAR complied with the official specifications for weight version, diameter, thickness and hardness, friability, and disintegration tests except for the hardness value of ATR. All authorized brands agreed with the label claims whereas some smuggled brands contained the appropriate active ingredients but did not contain the right amounts.

Objective assessment of the variation in number of doses of generic timolol eye drops along with their cost effectiveness.

First, this study aims to ascertain if truly the generic timolol eye drops circulating in Abuja and it environ are interchangeable. Secondly, we explore their cost effectiveness in naira based on the dispensing position. Using official guidelines, we assessed seven generic timolol ophthalmic preparations for organoleptic, pH, viscosity, sterility, and assay test. After this, they were tested in the vertical (90 ⁰) and horizontal (30 ⁰) positions for filled volume in a bottle, the total number of drops per bottle, drops per mL; and eventually the total number of bottles needed per year, cost per year and their cost effectiveness per mmHg were extrapolated. All brands were colorless and devoid of particulate contamination. Assay, pH, and viscosity values were within the compendia specification (BP and USP) for eye drops. The sterility assay showed no evidence of bacterial or fungi growth. All brands had actual filled volume less than or equal to the stated label claim. Their drops per 5 mL bottle range from 141-169 and 122-139 when dispensed in vertical and horizontal positions respectively; while for brands with 10 mL label volume, they range from 305-321 and 299-309 drops per bottle for vertical and horizontal dispensing respectively. Brand T1 (which is the most expensive) would need two bottles less in a year if the medication were to be dispensed vertically, amounting to N 3,200.00 ($ 7.04) reduction in treatment cost and a 45 % improvement in cost-effectiveness per intraocular pressure (IOP) reduction per year. In conclusion, the dispensing technique played a significant role in the number of drops per bottle, this would however impact on the treatment cost of glaucoma patient placed on timolol eye drop.

AWARENESS OF AGRO INPUT DEALERS ABOUT INSECTICIDE LABEL CLAIMS

Insecticide label claims are important sources of information for the farmers and the agro input dealers who sell them. They provide information about the active ingredients, mode of action, target pests, dosage, application method, safety precautions and environmental impact of the insecticides. However, the awareness level of the agro input dealers about these label claims is not well known. This study aimed to assess the awareness level of 120 agro-input dealers in Beed district of Maharashtra state, India, about the insecticide label claims and their toxicity labels. The study also examined the relationship between the profile of the agro input dealers and their awareness level, and identified the constraints and suggestions of the agro-input dealers regarding the insecticide label claims. The study used a structured questionnaire to collect data from the respondents through personal interview method. The data were analysed using frequency, percentage, mean, standard deviation and correlation coefficient. The results showed that the majority of the agro-input dealers had low to medium level of awareness about the insecticide label claims and their toxicity labels. The profile variables such as age, education, experience, training and membership in association had significant positive correlation with their awareness level. The major constraints faced by the agro input dealers were lack of training, inadequate display of label claims, complex language of label claims and low literacy level of farmers. The major suggestions given by the agro input dealers were to provide regular training, simplify the language of label claims, increase the font size and colour contrast of label claims and educate the farmers about the importance of label claims.

An assessment of qualitative and quantitative cannabinoids analysis in selected commercially available cannabis oils in Argentina

In recent years, the therapeutic use of cannabis products, especially cannabis oils, has increased significantly, due to the pharmacological potential of their cannabinoids, for the treatment of conditions, such as pain management, cancer, and epilepsy. In Argentina, patients with medical prescriptions can access to cannabis oil, through self-cultivation, a third-person (grower or importer), or a civil organization authorized for that purpose. However, these products remain largely unregulated in Argentina, and information available regarding labeling accuracy, especially cannabidiol (CBD)/ Δ9-tetrahydrocannabinol (Δ9-THC) concentrations are inconsistent or nonexistent, nor long-term product stability, and lot to lot variability. Understanding these properties is fundamental if these products are to be used in patients with a determinate pathology. Therefore, we analyzed commercially available cannabis oils (n: 500) in Argentina for qualitative and quantitative cannabinoids content. In order to provide a detailed overview of their cannabinoids profiles, and determine Δ9-THC, CBD, and cannabinol (CBN) concentrations, samples were diluted and analyzed by gas chromatography– mass spectrometry (GC/MS). Most of the samples tested positive for cannabinoids (n: 469) with Δ9-THC and CBD as the predominant cannabinoids. Among products tested, only 29.8% (n: 149) gave specific CBD label claims, and testing indicated a CBD tested positive of 70.5% (n: 105). For products (n: 17) with a THC-free label claim, testing indicated 76.5% (n: 13) of Δ9-THC positive, and cannabinoids were not detected in four products. Δ9-THC concentrations ranged from 0.1 to 143.0 mg/mL, CBD concentrations from 0.1 to 125.3 mg/mL, and CBN concentrations from 0.04 to 60.10 mg/mL; CBN/ Δ9-THC ratios ranged from 0.0012 to 2.31, and CBD/ Δ9-THC ratios from 0.0008 to 178.87. Furthermore, the (Δ9-THC + CBN)/CBD ratio of most samples was greater than one. In summary, our results indicate that cannabis oil products show wide variability in cannabinoids content, purity, and labeling.

Precise nutritional labelling of sliced packaged dry-cured ham using multi-energy X-ray absorptiometry

New consumer demands have increased the need for improved food processing and new value-added products that meet the latest quality standards. Changes in eating habits may lead to a preference for lower sodium products, making accurate labelling and nutritional claims important for the industry. The aim of this work was to study the application of Multi-energy X-ray absorptiometry (MEXA) for the determination of nutritional information in sliced packaged dry-cured ham for the industry. The effect of the acquisition conditions, the analysis approach, fat content and measured area of slices, as well as the potential of this technology for the inclusion of a verified ‘salt reduced’ nutritional claim, were analyzed in two industrial case studies. Two hundred and ten packets of sliced dry-cured ham were scanned using MEXA equipment. Two regions of interest were selected to study the effect of thickness on the model's precision. Salt content could be predicted with a RMSEP of 0.346% and 0.403% when acquisition conditions were 80 keV and 110 keV respectively. When used by the industry, the classification performance for a ‘salt reduced’ labelling claim depends on the mean salt content and heterogeneity of the company's production and on the threshold value selected for class definition. However, to support consumers personalized nutrition through precise labelling, implementation of MEXA technology together with labelling system is necessary.

Integrating qualitative interviews in drug development and the use of qualitative evidence in product labelling and health technology assessments: a review.

Including qualitative research in clinical trial design is an innovative approach to understanding patients' perspective and incorporate the patient's voice in all stages of drug development and evaluation. This review aims to explore current practices, lessons learned from the literature, as well as how qualitative interviews are considered by health authorities for marketing authorization and reimbursement. A targeted literature review of Medline and Embase databases was conducted in February 2022 to identify publications on qualitative methods embedded in clinical trial of pharmaceutical products. An additional search of guidelines and labeling claims of approved products regarding qualitative research was performed in various sources of grey literature. From the 24 publications and nine documents reviewed, we identified the research questions addressed with qualitative methods during clinical trials (e.g., change in quality of life, symptoms assessment, treatment benefit), preferred data collection methods (e.g., interviews), and data collection points (e.g., baseline and exit interviews). Moreover, the data from labels and HTAs demonstrate that qualitative data can play an important role in approval processes. The use of in-trial interviews is still emerging and is not yet common practice. Although the industry, scientific community, regulatory agencies and HTAs are showing an increasing interest in the use of evidence generated via in-trial interviews, guidance from regulators and HTAs would be helpful. Developing new methods and technologies to address the common challenges for such interviews is key to progress.

Adoption of label claim recommendation by cotton growers

The present study adoption of label claim recommendation by cotton growers was conducted in the year 2021-2022 in Dhamangaon Rly tehsil of Amravati district. The study was planned to investigate adoption of label claim recommendation by cotton growers. The exploratory design of social research was used for the present investigation.The data was collected by personally interviewing the respondents with help of presented structured schedule,120 cotton growers constituted 12 cotton growers from each village consisting of 10 villages was the sample for this study. The statistical methods such as mean, frequency, standard deviation and correlation were used. The findings of correlation analysis revealed that characteristics such as social participation and risk orientation were found positive and highly significant with adoption at 0.01 per cent level of probability, whereas annual income and innovativeness had positively significant with adoption at 0.05 per cent level of probability. The variables age, education, land holding, area under cotton crop were found no relationship with adoption so these were nonsignificant.

How Much Evidence Is Enough? Research Sponsor Experiences Seeking Regulatory Acceptance of Digital Health Technology-Derived Endpoints

Introduction: Digital health technologies (DHTs) provide opportunities for real-time data collection and assessment of patient function. However, use of DHT-derived endpoints in clinical trials to support medical product labelling claims is limited. Methods: From November 2020 through March 2021, the Clinical Trials Transformation Initiative (CTTI) conducted a qualitative descriptive study using semi-structured interviews with sponsors of clinical trials that used DHT-derived endpoints. We aimed to learn about their experiences, including their interactions with regulators and the challenges they encountered. Using applied thematic analysis, we identified barriers to and recommendations for using DHT-derived endpoints in pivotal trials. Results: Sponsors identified five key challenges to incorporating DHT-derived endpoints in clinical trials. These included (1) a need for additional regulatory clarity specific to DHT-derived endpoints, (2) the official clinical outcome assessment qualification process being impractical for the biopharmaceutical industry, (3) a lack of comparator clinical endpoints, (4) a lack of validated DHTs and algorithms for concepts of interest, and (5) a lack of operational support from DHT vendors. Discussion/Conclusion: CTTI shared the interview findings with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and during a multi-stakeholder expert meeting. Based on these discussions, we provide several new and revised tools to aid sponsors in using DHT-derived endpoints in pivotal trials to support labelling claims.

Proteins and Minerals in Whey Protein Supplements.

Sports nutrition supplementation is a widespread practice. Whey protein supplements contribute not only to protein intake but also to dietary exposure to minerals. The labelling present provides the percentage of protein and rarely refers to other components, such as potentially toxic elements such as B, Cu, Mo, Zn, and V that present tolerable upper intake levels set by the European Food Safety Authority. The percentage of protein declared on supplement labelling was checked using the Kjeldahl method, and the levels of Ca, Mg, K, Na, Ba, B, Co, Cu, Cr, Sr, Fe, Li, Mn, Mo, Ni, V, Zn, and Al were analyzed by ICP-OES with the aim of characterizing the protein and mineral contents of isolate and concentrate whey protein supplements representative of the European market. The protein content was 70.9% (18-92.3%) and statistically significant differences were observed between the declared and real protein percentages. Among the minerals, K (4689.10 mg/kg) and Ca (3811.27 mg/kg) presented the highest levels, whereas Co (0.07 mg/kg) and V (0.04 mg/kg) showed the lowest levels. It was concluded that the quality and safety of these products needs to be monitored and regulated. A high degree of non-compliance with labelling claims was detected. Furthermore, the contributions to the recommended and tolerable intakes among regular consumers need to be assessed.

Homogeneity of Two Semisolid Formulations Using Simple In-tube Mixing Method

To accelerate therapeutic effects, the mixtures of two or more topical pharmaceutical products having different medicinal purposes are often applied in the medical field. In this study, we aimed to develop a simple mixing method/procedure to achieve excellent homogeneity in the mixture of two topical products, a steroidal ointment and a skin moisturizer. To assess an in-tube mixing method as a simple mixing procedure, we injected both topical products into an empty resin tube, a flexible hollow tube with an open end that can be closed on one side, and a closed end on the other, removed as less air as possible inside the tube, and then thermocompressed (sealed) the open end to close it. The two topical products were then mixed uniformly by repeated finger pressure along the longitudinal axis of the tube. The homogeneity of the two topical products in the tube was evaluated by measuring the content of methyl paraoxybenzoate (MP), an additive loaded in the skin moisturizer. In addition, the mixability was qualitatively evaluated from the distribution of white petrolatum, another additive loaded in the steroid ointment, using Raman spectroscopy. As a result, the measured value of MP relative to the label claim was in the range of 100±12%, and the coefficients of variation value was also less than 12%. These results indicate that the in-tube mixing method using two topical products is approximately hologenetic preparations that do not cause therapeutic problems.

P39 Patient-Reported Outcomes As Endpoint in Oncology Trials: An Analysis of FDA and EMA Claims

Patient-Reported Outcomes (PROs) capture patient’s subjective perception of the effects of a disease or treatments. Previous reports have indicated that regulators have different approaches in inclusion of PROs as endpoint measures in the drug approval process. We aim at highlighting such differences by investigating the current use of PROs, as endpoints in oncology trials and label claims granted by the FDA in comparison with the EMA.

Stability Indicating RP-HPLC Method Development and Validation for the determination of Pretomanid an anti-bacterial drug

A new simple, rapid, accurate and stability indicating RP-HPLC method have been developed and validated for estimation of Pretomanid is an anti-bacterial agent in pharmaceutical dosage form. The RP-HPLC analysis was performed by using Xtimate C18 column (250mm × 4.6mm; 5µm) with Methanol: Acetonitrile: Ammonium phosphate buffer in the ratio of 55:40:05 (v/v/v) as mobile phase at a flow rate of 1.0mL/min and detected at 262nm wavelength. The calibration curve was linear over the concentration range from 10 to 40µg/mL and correlation coefficient was found to be 0.99. LOD and LOQ were estimated as 0.30µg/mL and 5.0µg/mL respectively. The % recovery was achieved from 98.67% to 99.96%. The method was applied for estimation in its pharmaceutical dosage form and assay result was 98.9% label claim. Proposed method showed excellent linearity, accuracy, precision, specificity, robustness, LOD, LOQ, and system suitability results within the acceptance criteria as per ICH guidelines. The Pretomanid drug was subjected to stress condition of Hydrolysis, Oxidation, Photolysis and Thermal degradation, Forced degradation study was carried out and the degradation products were well resolved from the pure Pretomanid drug. The proposed method was successfully applied for the estimation of Pretomanid drugs in commercial dosage form.

Pharmacopeial quality of artemether–lumefantrine anti-malarial agents in Uganda

BackgroundSubstandard anti-malarial agents pose a significant challenge to effective malaria control and elimination efforts especially in sub-Saharan Africa. The quality of anti-malarials in most low-and-middle income countries (LMICs) is affected by several factors including inadequate regulation and limited resources. In this study, the pharmacopeial quality of artemether–lumefantrine (AL) in low and high malaria transmission settings in Uganda was assessed.MethodsThis was a cross-sectional study conducted among randomly selected private drug outlets. The AL anti-malarials available in drug outlets were purchased using overt method. The samples were screened for quality using visual inspection, weight uniformity, content assay and dissolution tests. The assay test was done using liquid chromatography–mass spectrometry (LC–MS). The samples were considered substandard if the active pharmaceutical ingredient (API) content was outside 90–110% range of the label claim. Dissolution test was conducted following United States Pharmacopoeia (USP) method. Data was analysed using descriptive statistics and presented as means with standard deviations, frequencies, and proportions. Correlation between medicine quality and independent variables was determined using Fisher’s exact test of independence at 95% level of significance.ResultsA total of 74 AL anti-malarial samples were purchased from high (49/74; 66.2%) and low (25/74; 33.8%) malaria transmission settings. The most common batch of AL was LONART, 32.4% (24/74), with 33.8% (25/74) being ‘Green leaf’. Overall prevalence of substandard quality artemether–lumefantrine was 18.9% (14/74; 95% CI: 11.4–29.7). Substandard quality AL was significantly associated with setting (p = 0.002). A total of 10 samples (13.5%) failed artemether content assay test while, 4 samples (5.4%, 4/74) failed the lumefantrine assay test. One sample from a high malaria transmission setting failed both artemether and lumefantrine assay content test. Of the samples that failed artemether assay test, 90% had low (< 90%) artemether content. All the samples passed visual inspection and dissolution tests.ConclusionArtemether–lumefantrine agents, the recommended first-line treatment for uncomplicated malaria with APIs outside the recommended pharmacopeial content assay limit is common especially in high malaria transmission settings. There is need for continuous surveillance and monitoring of the quality of artemisinin-based anti-malarials across the country by the drug regulatory agency.

Development and Validation of Green and High-Throughput Microwell Spectrophotometric Assay for the Determination of Selective Serotonin Reuptake Inhibitors in Their Pharmaceutical Dosage Forms.

This study describes the development and validation of a new green and high-throughput microwell spectrophotometric assay (MW-SPA) for the determination of three selective serotonin reuptake inhibitors (SSRIs) in their pharmaceutical dosage forms. These SSRIs are fluoxetine, fluvoxamine, and paroxetine, the most prescribed drugs for the treatment of depression. The proposed assay was based on the formation of orange-colored N-substituted naphthoquinone derivatives upon the reaction of SSRIs with 1,2-naphthoquinone-4-sulphonate (NQS) in alkaline media. The assay was conducted in 96-microwell assay plates, and the absorbances of the reaction products were measured by a microplate reader at their maximum absorbance wavelengths. The optimum conditions of the reaction were refined and established. Under these conditions, calibration curves were generated, and linear regression equations were computed. The linear relations between the absorbances and drug concentrations were linear with good correlation coefficients (0.9992-0.9997) in the range of 2-80 µg/mL. The assay limits of detection were in the range of 1.5-4.2 µg/mL. The precision was satisfactory as the values of relative standard deviation did not exceed 1.70%. The accuracy of the assay was ≥98.2%. The proposed MW-SPA was successfully applied to the analysis of the SSRIs in their pharmaceutical dosage forms with acceptable accuracy and precision; the label claims were 99.2-100.5% (±0.96-1.35%). The results of the proposed MW-SPA were compared with those of the official/pre-validated assays by statistical analysis with respect to the accuracy (by t-test) and precision (by F-test). No significant differences were found between the calculated and theoretical values of the t- and F-tests at the 95% confidence level, proving similar accuracy and precision in the determination of SSRIs by both assays. The greenness of the proposed assay was confirmed by two metric tools. In addition, the assay is characterized with a high-throughput property which enables the simultaneous analysis of many samples in a short time. Therefore, the assay is a valuable tool for rapid routine application in pharmaceutical quality control units for the determination of the investigated SSRIs.

Parental perception of children's school lunch milk

School lunch programs are mandated by the US Code of Federal Regulations to serve pasteurized milk that is skim or 1% fat and fortified with vitamins A and D. In recent years, proposals have been made to alter nutritional requirements for school lunches and school lunch milk, including changes to the milk fat and flavor options available. The objective of this study was to evaluate parental understanding and perception of school lunch milk to better understand how changes to school lunch milk are perceived by parents. Four focus groups (n = 34) were conducted with parents of school-aged children (5-13 yr) who purchased milk as part of a lunch at school. Participants were asked about school lunch milk, including nutritional content, packaging, and flavoring. Focus groups included a build-your-own milk activity and discussion of children's milk products currently available on the market. Two subsequent online surveys were conducted with parents of school-aged children (survey 1, n = 216; survey 2, n = 133). Maximum difference scaling was used to evaluate what beverages parents would prefer their child to drink at school (survey 1) and which attributes of chocolate milk for children were most important to parents (survey 2). An adaptive choice-based conjoint activity (survey 1) included flavor, milk fat, heat treatment, label claims, and packaging type. Both surveys included questions to evaluate knowledge of milk nutrition and attitudes regarding milk and flavored milk. Agree/disagree questions were used in both surveys to assess parental opinions of school lunch milk. Survey 2 also included semantic differential (sliding scale) questions to assess parental opinions of chocolate milk and their acceptance of sugar alternatives in chocolate milk served in schools. Parents were familiar with the flavor options and packaging of school lunch milk, but expressed limited familiarity with school lunch milk fat content. Parents perceived milk to be healthy and a good source of vitamin D and calcium. From survey results, parents placed the highest importance on school lunch milk packaging, followed by milk fat percentage and flavoring over label claims and heat treatment. The ideal school lunch milk for parents was unflavored (white milk) or chocolate, 2% fat, and packaged in a cardboard gabletop carton. For school lunch chocolate milk, 3 distinct clusters of parents with differing opinions for children's chocolate milk were identified. Parents are largely unfamiliar with the specific attributes and nutritional profile of milk served in schools but believe that schools should offer milk to their children as part of breakfast and lunch. Parents in both surveys also displayed a preference for 2% fat milk over low-fat options, which provides actionable insight for both governmental bodies determining educational and nutritional policies for school meals and fluid milk producers seeking to optimize their products intended for schools.

Authentication of Tinospora cordifolia derived herbal supplements using high resolution mass spectrometry-based metabolomics approach – A pilot study

Tinospora cordifolia herbal supplements have recently gained prominence due to their promising immunomodulatory and anti-viral effects against SARS-CoV-2. Mislabelling or diluting Tinospora supplements for profit may harm public health. Thus, validating the label claim of these supplements in markets is critical. This study investigated how high resolution mass spectrometry-based metabolomics and chemometrics can be used to distinguish Tinospora cordifolia from two other closely related species (T. crispa and T. sinensis). The Orthogonal Partial Least Square Discriminant Analysis (OPLS-DA) and PLS-DA based chemometric models predicted the species identity of Tinospora with 94.44% accuracy. These classification models were trained using 54 T. cordifolia, 21 T. crispa, and 21 T. sinensis samples. We identified 7 biomarkers, including corydine, malabarolide, ecdysterone, and reticuline, which discriminated Tinospora cordifolia from the two other species. The label claim of 25 commercial Tinospora samples collected from different parts of India was verified based on the relative abundance of the biomarker compounds, of which 20 were found authentic. The relative abundance of biomarkers significantly varied in the 5 suspicious market samples. This pilot study demonstrates a robust metabolomic approach for authenticating Tinospora species, which can further be used in other herbal matrices for product authentication and securing quality.

Development of Simple VU Spectrophotometric Method for the Estimation of Bambuterol Hydrochloride in Bulk and Its Formulations

A simple, rapid and highly sensitive spectrophotometric method has developed for the estimation of Bambuterol hydrochloride in bulk and marketed tablet dosage form. In distilled water, Bambuterol showed absorbance at 264nm. Linearity was observed in the conc range of 200-1000 μg/ml (r2 = 0.9990). The assay results were found to be in a good agreement with label claim. The recovery studies were carried at 3 different levels i.e, at 100%, 150%, 200%. The accuracy of the method was conformed by recovery studies of tablet dosage forms and was found to be 96.43% for bambuterol hydrochloride. The method was validated stastically and by good recovery with % RSD is less than 2Thus the proposed method was found to be rapid, specific, precise, accurate and cost-effective quality control tool for the routine analysis of bambuterol hydrochloride in bulk and combined dosage form.

Extraction and Quantification of Ano Rectal Formulation by UV-LC Techniques

Suppositories very popular formulations and are currently used therapeutically all over the world. Especially in pediatrics, where they can be used for the effective lowering of high fever accomplished with seizure. The choice of a suppository as the mode of drug delivery system in all cases even in infants when oral delivery is impossible, that is an unconscious or vomiting patient, or in the case of infants. Therefore, the quality control study of this dosage form with a modern instrumental analytical technique is highly desired. In consequence of the increased application of suppositories, there is a current demand for a rapid, effective analytical methods required for routine analysis. The literature search revealed that methods for the UV and high-performance liquid chromatography (HPLC) analysis of DZP are very rare.Thereforethe aim of the present research was to develop and validate a suitable general sample preparation and chromatography method for suppositories containing DZP. The primary method (I) is based on UV Spectroscopy. UV spectra of Diazepam are recorded. The secondary method is based on the Reverse phase HPLC method was developed. The UV detector was operated at 286nm. After method development the proposed method was validated as per ICH guidelines. The developed method was accurate and precise which shows the evident from the analytical data and recovery studies. The analytical results were in good and it complies with the label claims.

The analysis of cannabinoids in e-cigarette liquids using LC-HRAM-MS and LC-UV

The use of cannabidiol or CBD products has skyrocketed in the last five years due to the alleged therapeutic benefits, a low potential for abuse and lack of the typical psychoactive effects associated with the use of cannabis products containing high levels of ∆9-tetrahydrocannabinol (∆9-THC). In Belgium, CBD-containing e-liquids with a total THC content lower than 0.2% (w/w) are currently legal. In order to verify the compliance of the different CBD-containing e-cigarette liquids that are available to the Belgian population, a method was developed for screening of 17 cannabinoids and to quantify the major cannabinoids such as CBD, CBDA, ∆9-THC and ∆9-THCA. The latter was fully validated using the ‘total error’ approach, applying accuracy profiles and conforming to ISO17025. None of the analysed samples exceeded the legal limit for the total amount of ∆9-THC present. However, of the 20 CBD-liquids investigated in this study, only 30% of the samples contained an amount of CBD that was within 10% deviation of the label claim. Moreover, the CBD e-liquids labelled “full/broad spectrum” consisted of several minor alkaloids in comparison to the “classic” CBD e-liquids where the acidic forms of the cannabinoids were not present. Currently, no legislation is available for the regulation of CBD e-liquids, however these results indicate that quality controls are pertinent especially concerning the discrepancy in CBD label accuracy.