Pharmaceutical Analysis Research Articles

Environmental Sample Stability for Pharmaceutical Compound Analysis: Handling and Preservation Recommendations.

Efficient and resilient techniques for handling samples are essential for detecting pharmaceutical compounds in the environment. This study explores a method for preserving water samples during transport before quantitative analysis. The study investigates the stability of 17α-ethynylestradiol (EE2), acetaminophen (ACM), oxytetracycline (OTC), sulfamethoxazole (SMX), and trimethoprim (TMP) after preconcentration within solid-phase extraction (SPE) cartridges. Through various experiments involving different holding times and storage temperatures, it was determined that four pharmaceutical compounds remained stable when stored for a month at 4°C and for six months when stored at -18°C in darkness. Storing these compounds in SPE cartridges at -18°C seemed effective in preserving them for extended periods. In addition, ACM, TMP, OTC, EE2, and SMX remained stable for three days at room temperature. These findings establish guidelines for appropriate storage and handling practices of pharmaceutical compounds preconcentrated from aqueous environmental samples using SPE.

Forensic and Pharmaceutical, Chemical and Toxicological Analysis of Medical Drugs and Substances in Illegal Circulation in Ukraine

Recent years have witnessed a surge in the illegal circulation of medical drugs and substances in Ukraine, necessitating a comprehensive approach to their identification and analysis. This study delves into the forensic, pharmaceutical, chemical, and toxicological analyses of these substances, elucidating their origin, composition, and potential harm. Utilizing advanced chromatographic and spectroscopic techniques, the research provides an in-depth profile of commonly abused drugs and substances, many of which are cleverly disguised under seemingly benign nomenclatures. Forensic examinations highlighted the sophistication of counterfeit techniques that mimic legitimate pharmaceutical products, posing significant health risks to unsuspecting consumers. The toxicological assessments underscored the severe health implications associated with consumption, from acute poisoning to long-term physiological complications. This paper sheds light on the intricate nexus of illegal drug trafficking in Ukraine, emphasizing the urgency for robust pharmaceutical regulation, advanced forensic capabilities, and public awareness campaigns. Through its interdisciplinary approach, this research underscores the critical need for collaborative efforts among healthcare professionals, law enforcement agencies, and policymakers to combat the escalating menace of illicit drugs and safeguard public health. Fatal cases due to poisoning by psychoactive substances of various classification and legal groups were systematized. Features of forensic and pharmaceutical, chemical and toxicological analysis were indicated. Attention was focused on the classification of means and substances according to the current legislation of Ukraine. The experience of the Department of Pharmacy of the Luhansk State Medical University in Rivne for the development of forensic and pharmaceutical, chemical and toxicological analysis in Ukraine was presented.

Statistical reliability of a relative standard deviation of chromatographic peak area estimated by a chemometric tool based on the FUMI theory

In pharmaceutical analysis using a high-performance liquid chromatography (HPLC) system, repeatability assessment is significant to obtain reliable and precise quantitative results. The purpose of the present study is to experimentally show the statistical reliability of a relative standard deviation (RSD) of peak area estimated by a chemometric tool based on probability theory, called the function of mutual information (FUMI) theory, which stochastically provided an RSD of peak area and SD of baseline areas with width k (s(k)) from noises and a signal on a single chromatogram. An ultra-high-performance liquid chromatography with ultraviolet detection (UHPLC-UV) for determining ergosterol was applied as an example of the repeatability assessment. In addition, the statistical reliability of an RSD of peak area in the UHPLC-UV system was certified according to a chi-square (χ2) distribution. The 712 values of s(k) were experimentally obtained from a data series of 1001 points in the noise regions of 712 chromatograms. The histogram of χ2 of s(k) was well-fitted to the χ2 distribution curve (freedom degree, ν = 50), indicating that the statistical reliability of an RSD of the peak area in the UHPLC-UV estimated by the FUMI theory (n = 1) was equivalent to that estimated by 50 runs of chromatographic measurements.

A COMPARATIVE STUDY ON CONVENTIONAL AND ADVANCE TECHNIQUES FOR PLANT EXTRACTION AND EFFECT ON THE EXTRACT YIELD: REVIEW

Medicinal plants are bringing so much attention from the researchers, nutritionists and consumers due to their potent nutritional value and ethno-medicinal properties. Extraction plays a critical role to study the medicinal properties of plants, herbs and spices. The present review was conducted to elaborate the advance method of extraction with small use of solvent and better yields of extract in short time duration. Nowadays purity is a major concern for the researcher to evaluate effective analysis. To obtain the phytochemicals from the plant majorly depends on the extraction procedure. Inappropriate extraction may cause loss in quantitative phyto-components. Advance methods like MAE, ASE, SPE and UAE are studied on compare with conventional methods on the basis of yield, efficacy and purity of extracts. In this review article, commonly used extraction techniques discussed based on their strength to obtain high yields and better purity of extract to assess the economical attainability of the methods and further used for chemical, biological and pharmaceutical analysis.

Automation of Drug Discovery through Cutting-edge In-silico Research in Pharmaceuticals: Challenges and Future Scope.

The rapidity and high-throughput nature of in silico technologies make them advantageous for predicting the properties of a large array of substances. In silico approaches can be used for compounds intended for synthesis at the beginning of drug development when there is either no or very little compound available. In silico approaches can be used for impurities or degradation products. Quantifying drugs and related substances (RS) with pharmaceutical drug analysis (PDA) can also improve drug discovery (DD) by providing additional avenues to pursue. Potential future applications of PDA include combining it with other methods to make insilico predictions about drugs and RS. One possible outcome of this is a determination of the drug potential of nontoxic RS. ADME estimation, QSAR research, molecular docking, bioactivity prediction, and toxicity testing all involve impurity profiling. Before committing to DD, RS with minimal toxicity can be utilised in silico. The efficacy of molecular docking in getting a medication to market is still debated despite its refinement and improvement. Biomedical labs and pharmaceutical companies were hesitant to adopt molecular docking algorithms for drug screening despite their decades of development and improvement. Despite the widespread use of "force fields" to represent the energy exerted within and between molecules, it has been impossible to reliably predict or compute the binding affinities between proteins and potential binding medications.

[Research progress on preparation and applications of covalent organic framework-based chromatographic stationary phases].

Given continuous developments in industrial and scientific research, the separation and analysis of complex systems with high sensitivity, throughput, and selectivity is facing new challenges. Chromatography plays an irreplaceable role in separation science and is widely applied in environmental monitoring, pharmaceutical analysis, and food safety. Owing to their outstanding advantages, such as high loading capacity, precise quantification, and good reproducibility, chromatographic separation techniques based on various retention mechanisms have been utilized to detect different analytes. The stationary phase is the core material of chromatographic columns and has an extremely important influence on their separation performance. The selectivity and efficiency of separation largely depend on the chromatographic stationary phase. However, traditional stationary phases, such as silicon-based matrices, are characterized by complex preparation processes, poor permeability, large mass transfer resistance, and a narrow pH range. In addition, polymer matrices show poor mechanical stability and susceptibility to swelling, which limit their applications in the field of separation. Therefore, the development of novel stationary phases with the advantages of traditional stationary phases has become a research emphasis in the field of analytical science in efforts to meet separation requirements under different environments. Various stationary phases based on novel porous materials, such as metal organic frameworks (MOFs), porous organic cages (POCs), and covalent organic frameworks (COFs), are used for chromatographic separation. As mesh crystalline porous materials, MOFs have the advantages of a large surface area, adjustable structure, and easy functionalization; thus, they are widely used as chromatographic stationary phases in reverse-phase chromatography, hydrophilic-mode chromatography, mixed-mode chromatography, and other separation modes. However, because the pore size of MOFs is small and most MOFs demonstrate poor chemical stability under acidic or alkaline conditions, their applications in chromatographic separation are greatly limited. COFs are porous, crystalline polymer materials composed of light elements (H, O, C, N, B, and Si) connected via covalent bonds. Their advantages include a low density, large specific surface area, high porosity, good chemical and thermal stability, regular pores, and adjustable pore sizes. Because of their unique structures and properties, COFs are widely used in many fields such as catalysis, enrichment, gas capture, and sensing. COF materials are also suitable for separation analysis and considered ideal materials for novel chromatographic stationary phases. This review summarizes the latest research progress on the preparation and applications of COF-based chromatographic stationary phases over the past five years. First, the preparation of COF-based stationary phases (SiO2@COFs stationary phase, COFs monolithic stationary phase, pure COFs stationary phase and COFs-coated stationary phase) is introduced. The latest applications of COF-based stationary phases in the separation of organic compounds, isomers, and chiral compounds are then described in detail. Finally, the future development trends and challenges of chromatographic stationary phases based on COFs are discussed to provide new ideas for the future design and development of novel chromatographic stationary phases based on COFs.

Extemporaneous Preparations in the Pharmacotherapy of Nervous System Disorders: Pharmaceutical Management, Marketing, Analysis, Application

Pharmaceutical management, marketing, pharmaceutical analysis, clinical and pharmacological properties for the use of an extemporaneous drug in the pharmacotherapy of nervous system disorders were studied. The previous experience of the author in the development of new combined drugs of various clinical and pharmacological groups was used. The composition of an extemporaneous drug with sedative pharmacological properties (sodium bromide, novocaine, tincture of valerian) is proposed. The manufacturing technology in pharmacy conditions, qualitative and quantitative indicators of active substances, as well as storage conditions and shelf life of the new extemporaneous drug were developed. The search, development, manufacture in a pharmacy and the use of extemporaneous drugs will contribute to the improvement of planning, organization, and control of the processes of medical and pharmaceutical assistance to patients in conditions of armed conflict. Coordination of medical, pharmaceutical, human, financial, natural, technological, and social resources is necessary to meet the challenges of today.

Targeted Pharmaceutical Analysis of Antibiotic Use by Risk Criteria in Patients Hospitalized in the Infectious and Tropical Diseases Department at Treichville Teaching Hospital (Abidjan, Côte d'Ivoire)

Introduction: Most pharmacotherapeutic problems in hospitals are caused by anti-infectives. Audit of prescriptions by a clinical pharmacist is a control and prevention element for iatrogenic risks. Objective: The main aim of our study was to assess the use of antibiotics according to risk criteria in patients hospitalized in the infectious diseases Unit of the Treichville Teaching Hospital (Abidjan, Ivory Coast). Methods: This cross-sectional descriptive study conducted from August to December 2022 in the Infectious and Tropical Diseases department of the Treichville University Hospital aimed to analyze the use of antibiotics in patients with risk criteria. The tools for detecting pharmacotherapeutic problems allowed us to evaluate the frequency and nature of pharmaceutical interventions, highlighting the role of the pharmacist in patient management. Data were analyzed using SPSS version 20.0 software (IBM, USA). Results: A total of 88 patients were included in the study, with a majority of singles (54.5%) and a predominance of subjects under 45 years of age (87.6%) and HIV-positive (93.2%). Antibiotics were the most frequent treatment (75.1%), followed by beta-lactams (36.7%). The main drug interactions were precautions for use (53.6%) and contraindicated associations (45.6%), especially the combination of Ofloxacin with bivalent cations or didanosine. The main pharmaceutical interventions proposed were monitoring of biological parameters in at-risk patients (68.8%) and drug substitution (14.8%). All proposed pharmaceutical interventions were accepted by prescribers. Risk criteria associated with the use of antibiotics were significantly associated with the nature of proposed pharmaceutical interventions. Conclusion: In conclusion, the use of antibiotics in patients with risk criteria is common in the Infectious and Tropical Diseases department of the Treichville University Hospital. The results emphasize the importance of prescription audit by a clinical pharmacist in detecting pharmacotherapeutic problems and preventing iatrogenic risks. The proposed pharmaceutical interventions were accepted by prescribers and were tailored to the risk criteria associated with the use of antibiotics.

Quality by Design Approach: Progress in Pharmaceutical method Development and Validation

Pharmaceutical analysis plays a significant role in pharmaceutical formulation quality assurance and control. Due to the pharmaceutical industries' rapid expansion and the production of pharmaceuticals all over the world, there is a greater need for novel analytical procedures in this sector. Establishing the identification, purity, physical properties, and potency of medications as well as the medication's bioavailability and stability is the goal of analytical method development. A few new drug applications were recently given regulatory flexibility by the Food and Drug Administration for an analytical method based on quality by design. With Quality by design, product design and development are performed methodically. Analytical methodologies have similar opportunities for implementing Quality by design as production procedures do. It consequently enhances formulation design, development efficiency, and capacity. The underpinnings of the QbD approach have been explored in this article due to their use in the creation and validation of analytical procedures. Additionally, a summary of experimental studies reporting the application of the QbD methodology to method development is included.

Solid-Phase Microextraction Techniques and Application in Food and Horticultural Crops.

Solid-phase microextraction (SPME) is a sample preparation technique which utilizes small amounts of an extraction phase for the extraction of target analytes from investigated sample matrices. Its simplicity of use, relatively short sample processing time, and fiber reusability have made SPME an attractive choice for many analytical applications. SPME has been widely applied to the sampling and analysis of environmental, food, aromatic, metallic, forensic, and pharmaceutical samples. Solid phase microextraction is used in horticultural crops, for example, to determine water and soil contaminants (pesticides, alcohols, phenols, amines, herbicides, etc.). SPME is also used in the food industry to separate biologically active substances in food products for various purposes, for example, disease prevention, determining the smell of food products, and analyzing tastes. SPME has been applied to forensic analysis to determine the alcohol concentration in blood and that of sugar in urine. This method has also been widely used in pharmaceutical analysis. It is a solvent-free sample preparation technique that integrates sampling, isolation, and concentration. This review focuses on recent work on the use of SPME techniques in the analysis of food and horticultural crops.

Estimation of Oleanolic Acid by HPTLC and HPLC Methods in Successive Leaf Extracts of Leucas aspera and Tridax procumbens and their In vitro Anti-Inflammatory Activity

Aims: The study was started with the goal of quantifying the oleanolic acid from consecutive leaf extracts of Leucas aspera and Tridax procumbens using a marker oleanolic acid by utilizing HPTLC and HPLC techniques, as well as to perform an evaluation of their antiinflammatory activity.
 Place and Duration of Study: The study was carried out between October 2022 and June 2023 in the Department of Pharmaceutical Analysis and Pharmacognosy, Sri Ramakrishna Institute of Paramedical Sciences, College of Pharmacy, Coimbatore-44, Tamil nadu, India.
 Methodology: The extraction of leaves is done using successive extractions by Continuous hot percolation method using soxhlet extractor. Petroleum ether, ethyl acetate and methanol fractions for which the phytochemical analysis were conducted. Standardization of oleanolic acid was performed by using HPTLC and HPLC techniques. Quantification of oleanolic acid in the two plants sequential leaf extracts were done. In vitro study of antiinflammatory activity was performed by Xanthine oxidase inhibitory activity in the ethyl acetate fraction.
 Results: Alkaloids, glycosides, terpenoids, steroids, flavonoids, saponins, carbohydrates, and proteins were all found in the two plant extracts by using phytochemical screening. In HPTLC method, petroleum ether, ethyl acetate and methanol leaf extracts of Leucas aspera and Tridax procumbens were developed in suitable mobile phase of toluene: ethyl acetate: formic acid (7:3:0.2%v/v/v) followed by derivatizing with anisaldehyde sulphuric acid derivatizing agent and scanned under 530nm. HPLC of standard marker and successive leaf extracts of Leucas aspera and Tridax procumbens were carried out using methanol: 25mM phosphate buffer (pH-3) in the ratio of 90:10% v/v at flow rate of 1ml/min and chromatograms were recorded at 202nm. Xanthine oxidase inhibitory activity of combined leaf extracts of ethyl acetate showed IC50 value of 0.026μg/ml. 
 Conclusion: Standardization of oleanolic acid was conducted by HPTLC and HPLC methods and linearity were found to be 0.9964 and 0.9998 respectively. Quantification of oleanolic acid in successive leaf extracts of the two plants were conducted. In vitro study using xanthine oxidase inhibitory activity showed that combined extracts of ethyl acetate fractions exhibited better antiinflammatory property than the individual extracts of the selected plants.

Analysis of the iron states in iron-containing pharmaceutical products using Mössbauer spectroscopy

Iron-containing pharmaceuticals, namely: (i) PreNatal with ferrous fumarate, (ii) Tardyferon® with ferrous sulfate, (iii) Fenules with water free ferrous sulfate, (iv) Iron Complex with iron glycinate, citrate, (v) Gentle Iron, (vi) Hema-Plex® and (vii) Iron Bisglycinate with iron (ferrous) bisglycinate chelate (iron compounds are given as declared by the manufactures) were studied by 57Fe Mössbauer spectroscopy with X-ray diffraction and magnetization measurements for analysis of the iron state. The obtained results demonstrate that the iron compound announced by the manufacturer in each pharmaceutical is not homogeneous and exists as some modifications of this compound or results of its transformation/oxidation probably due to its instability. The presence of ferrous and ferric compounds is observed, and the relative ferric iron fractions are roughly determined for each pharmaceutical product. This analysis clearly shows the differences between the iron compounds proclaimed by the manufacturers and those obtained by Mössbauer spectroscopy. That justifies as to why this technique should be used for the control and analysis of the iron-containing pharmaceuticals.

Solid-Phase Spectrometric Determination of Organic Thiols Using a Nanocomposite Based on Silver Triangular Nanoplates and Polyurethane Foam.

Adsorption of silver nanoparticles on polymers may affect the processes in which they participate, adjusting the analytical characteristics of methods for the quantitation of various substances. In the present study, a composite material based on silver triangular nanoplates (AgTNPs) and polyurethane foam was proposed for chemical analysis. The prospects of its application for the solid-phase/colorimetric determination of organic thiols were substantiated. It was found that aggregation of AgTNPs upon the action of thiols is manifested by a decrease in the AgTNPs' localized surface plasmon resonance band and its significant broadening. Spectral changes accompanying the process can be registered using household color-recording devices and even visually. Four thiols differing in their functional groups were tested. It was found that their limits of detection increase in the series cysteamine < 2-mercaptoethanol < cysteine = 3-mercaptopropionic acid and come to 50, 160, 500, and 500 nM, respectively. The applicability of the developed approach was demonstrated during the analysis of pharmaceuticals and food products.

Qualitative and Quantitative Analysis of Azithromycin as Solid Dosage by Raman Spectroscopy.

Active pharmaceutical ingredients (APIs) and excipients are main drug constituents that ought to be identified qualitatively and quantitatively. Raman spectroscopy is aimed to be an efficient technique for pharmaceutical analysis in solid dosage forms. This technique can successfully be used in terms of qualitative and quantitative analysis of pharmaceutical drugs, their APIs, and excipients. In the proposed research, Raman spectroscopy has been employed to quantify Azithromycin based on its distinctive Raman spectral features by using commercially prepared formulations with altered API concentrations and excipients as well. Along with Raman spectroscopy, principal component analysis and partial least squares regression (PLSR), two multivariate data analysis techniques have been used for the identification and quantification of the API. For PLSR, goodness of fit of the model (R2) was found to be 0.99, whereas root mean square error of calibration was 0.46 and root mean square error of prediction was 2.42, which represent the performance of the model. This study highlights the efficiency of Raman spectroscopy in the field of pharmaceutics by preparing pharmaceutical formulations of any drug to quantify their API and excipients to compensate for the commercially prepared concentrations.

Natural Dye of Beetroot

In this study, a simple and indirect spectrophotometric method for the quantification of atenolol in pharmaceutical formulations, utilizing a natural food dye extracted from red beet root, is presented. The process involves the oxidation of atenolol in a 1 mol/LHCl acidic medium, using an excess of potassium persulfate. Subsequently, the resulting tablet solution is employed to fade the red beetroot dye, and the solution is measured spectrophotometrically. The optimized reaction conditions consist of a 16 µg/mL atenolol solution, 2.1 mL (100 µg/mL) of potassium persulfate, and 5 mL (100 µg/mL) of red beetroot dye. Spectrophotometric measurements were performed at 535 nm, and the linear range for quantification was found to be 4–22 µg/mL (R2 = 0.9987). The method exhibited a limit of detection of 0.01 µg/mL. Notably, the proposed method was successfully applied to analyze various commercial brands of pharmaceutical formulations; yielding results consistent with those obtained using the pharmacopeia method. This research offers a valuable and accessible technique for atenolol quantification, demonstrating potential significance in pharmaceutical analysis and quality control processes.

Insights into molecular docking: A comprehensive view

Molecular docking software is mainly used in drug development. Molecular docking offers a wide range of useful techniques for the creation and analysis of pharmaceuticals. Before now, predicting the target for a receptor was extremely challenging however, docking the target protein with a ligand is a straightforward and dependable procedure presently and binding affinity is designed. To see a molecule's three-dimensional structure, a variety of docking tools have been created. The docking score can also be examined using a variety of computational techniques. This review mainly emphases on the core idea of molecular docking, as well as its major uses and many kinds of interaction, Basics requirements for molecular docking, Molecular Approach, Application, and Software available for the Docking of molecules.

Multi-wavelength deep-ultraviolet absorbance detector based upon program-controlled pulsing light-emitting diodes

A novel approach for multi-wavelength ultraviolet (UV) absorbance detection has been introduced employing a single board computer (SBC) with a field programmable gate array (FPGA), Red Pitaya SBC, to generate separated micro pulses for three deep-ultraviolet light-emitting diodes (DUV-LEDs), λmax = 235, 250, and 280 nm, along with data acquisition and processing via a custom-made program. The pulse set generation and data acquisition were synchronized using the SBC. The outputs of the three pulsing DUV-LEDs were combined and transmitted to the flow cell via a solarisation resistant trifurcated optical fiber (OF). An ultra-fast responding photodiode was connected to the optical-fiber-compatible flow cell to record the intensity of the DUV pulses. Upper limit of detector linearity (A95 %) was found to be 1917 mAU, 2189 mAU, and 1768 mAU at 235 nm, 250 nm, and 280 nm, respectively, with stray light ≤0.9 %. In addition, the effective path length (Leff) was estimated to be ≥98.0 % of the length of the used flow cell (50 mm). The new pulsed multi-LEDs absorbance detector (PMLAD) has been successfully coupled with a standard liquid chromatograph and utilized for the analysis of pharmaceuticals. Paracetamol, caffeine, and aspirin were simultaneously determined at 250, 280, and 235 nm, respectively, using the PMLAD. The absorbance ratios between the different wavelengths were applied to further confirm the identity of the studied compounds. Excellent linearity was achieved over a range of 0.1–3.2 µg/mL for paracetamol, 0.4–6.4 µg/mL for caffeine, and 0.8–12.8 µg/mL for aspirin with a regression correlation coefficient (r2) ≥ 0.99996. The quantitation limits (LOQs) were 0.10 µg/mL, 0.38 µg/mL, and 0.66 µg/mL for paracetamol, caffeine, and aspirin, respectively.

Development of an impedimetric sensor for susceptible detection of melatonin at picomolar concentrations in diverse pharmaceutical and human specimens

Our investigation aimed to create and manufacture an electrochemical impedance sensor with the purpose of improving the detection efficiency of melatonin (ME). To achieve this objective, we employed gold nanoparticles coated on polydopamine formed in glassy carbon electrodes (AuNPs/PDA/GCE) as a means to enhance the sensor's capabilities. A novel approach employing the signal-off strategy and electrochemical impedance spectroscopy (EIS) technique was utilized to determine ME. When the AuNPs/PDA/GCE electrode was immersed in a buffered solution containing ME, and the oxidation current of AuNPs was recorded, it was observed that the oxidation current of AuNPs decreased upon the introduction of ME molecules. The decrease in electrical current can be ascribed to the inhibitory impact of ME molecule adsorption on the electrode surface with applying −0.2 V for 150 s in acetate buffer solution (ABS) (pH, 5) through various mechanisms, which hinders the electron transfer process crucial for AuNPs oxidation. Consequently, by utilizing EIS, various concentrations of ME were quantified spanning from 1 to 18 pM. Moreover, the ME sensor achieved an impressive detection limit of 0.32 pM, indicating its remarkable sensitivity in detecting low concentrations of ME. Importantly, these novel sensors demonstrated exceptional attributes in terms of sensitivity, specificity, stability, and repeatability. The outstanding performance of these sensors, coupled with their desirable attributes, establishes their considerable potential for a wide range of practical applications. These applications encompass various fields such as clinical diagnostics, pharmaceutical analysis, environmental monitoring, and industrial quality control, where accurate and sensitive detection of ME is of utmost importance.

HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE, AND DORAVIRINE

Objective: The objective of this study was to develop and validate an HPTLC method for the simultaneous estimation of Lamivudine, Tenofovir disoproxil fumarate, and doravirine. The method is aimed to provide reliable and efficient quantification of these drugs. Methods: The chromatographic separation of drugs was performed on aluminum plates coated with silica gel 60 F254. Samples were spotted on the plate as a 6 mm wide band using a linomat applicator and a 100 µl syringe. The mobile phase used was a mixture of ethyl acetate, methanol, and chloroform (07:02:01 % v/v/v). Densitometric scanning at 226 nm was conducted using a Deuterium lamp as the radiation source, and the data were analyzed using win CATS software. The method was validated following the ICH Guideline ICH Q2 (R1). Results: The optimized method lead to the resolution of drugs with the Rf values of doravirine (0.75±0.02), Tenofovir disoproxil fumarate (0.57±0.02), and lamivudine (0.37±0.02). Doravirine exhibited a linear range of 500-1500 ng/band with a favorable linear equation and regression coefficient of 0.999. Tenofovir disoproxil fumarate and lamivudine showed a linear range of 1500-4500 ng/band, and both compounds displayed a linear relationship with a regression coefficient of 0.997. The method's accuracy was assessed through recovery studies, and the LOD and LOQ were determined for each drug. Conclusion: The optimized HPTLC method was validated in this study, following the ICH Q2 (R1) guidelines, it demonstrates its efficacy for the quantitative analysis of Doravirine, Tenofovir disoproxil fumarate, and lamivudine. The method offers reliable quantification of these compounds in a combined dosage form and can be used for routine analysis in pharmaceuticals.

Pharmacognostical and Pharmaceutical Evaluation of Rasnadi Basti in the Management of Vandhyatvo w.s.r to Anovulation

Rasnadi basti is mainly indicated for the Vataj disorders i.e., Vibandha, Anaha, Aruchi, Shoola, Vandhyatva, Pradara, Prameha, Yonidosha, Pandu, etc. It is having properties like Sarvaroganivarana, Shukrajanana, Vrushya, and Pumsavana Parama. Acharya Siddhinandan Mishra has mentioned the effectiveness of Rasnadi basti in the treatment of Vandhyatva. Vandhyatva (infertility) has got many etiological factors; one among them is anovulation. Vata is governing factor of the whole reproductive physiology &amp; any vitiation in Vata may lead to anovulation. Basti Karma is the best choice for the treatment of Vata Dosha. In the study, Rasnadi Basti was given to one of the trial group having infertility due to anovulation. So, for the assurance of the quality of herbal compounds used to prepare Rasnadi basti, its pharmacognostic and pharmaceutical analysis was necessary. Methods: Freshly prepared Rasnadi Basti was subjected to microscopic evaluation for pharmacognostic &amp; physiochemical analysis like specific gravity &amp; solid content. Results: Pharmacognostical study showed the presence of certain identifying characteristics of the ingredients of Rasnadi basti i.e., Rasna, Eranda, Patala, Musta, Vacha, Pippli, Agnimantha, Kustha, Yastimadhu, etc. In pharmaceutical study, the preliminary physiochemical analysis showed solid content of 52.53% w/v &amp; specific gravity of 1.0242. Conclusions: Pharmacognostical and physico-chemical observations revealed the specific characteristics of all active constituents of Rasnadi basti and confirmed the purity and genuinity of the formulation.