Current Pharmaceutical Analysis最新文献

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Spectroscopic and Chromatographic Estimation of Some Sartans and their Combinations with Thiazide Diuretics: A Review 一些沙坦类药物及其与噻嗪类利尿剂联用的光谱和色谱评价综述
4区 医学
Current Pharmaceutical Analysis Pub Date : 2023-10-01 DOI: 10.2174/0115734129255763230927115653
Kajal Baviskar, Ramanlal Kachave
{"title":"Spectroscopic and Chromatographic Estimation of Some Sartans and their Combinations with Thiazide Diuretics: A Review","authors":"Kajal Baviskar, Ramanlal Kachave","doi":"10.2174/0115734129255763230927115653","DOIUrl":"https://doi.org/10.2174/0115734129255763230927115653","url":null,"abstract":"Abstract: Sartans are often used as antihypertensives. They are also available in combination with thiazide diuretics for the management of hypertension. Analytical method development is a crucial part of successful drug development and characterization. Bioanalytical studies are of paramount importance while establishing pharmacokinetic and toxicokinetic data while forced degradation studies are important to elucidate degradation pathways and to establish stability of the drugs. : Different methods have been developed for the analysis of sartans and their combination with thiazide diuretics. We thought it imperative to summarize them so the data could be useful for analysis of newer sartans. The review describes various methods for analysis of some frequently employed sartans as well as the latest sartans and their combination with thiazide diuretics. The article also focuses on their analysis of biological fluids. Forced degradation studies have also been covered in the article. : Article is divided into three sections. First section covers introduction, second section focuses on different methods developed, including bioanalytical methods, while third section presents forced degradation studies carried out on the drugs. Important parameters of the analytical methods developed have been summarized in tabular form.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135762577","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Development of Simple HPLC-UV Method for the Simultaneous Determination of Repaglinide, Dexamethasone, and Remdesivir, and its Application to Synthetic Mixture and Human Plasma 高效液相色谱-紫外同时测定瑞格列奈、地塞米松和瑞德西韦的方法建立及其在复方制剂和人血浆中的应用
4区 医学
Current Pharmaceutical Analysis Pub Date : 2023-10-01 DOI: 10.2174/0115734129263384230928052923
Miglena Smerikarova, Stanislav Bozhanov, Alexandrina Mateeva, Vania Maslarska
{"title":"Development of Simple HPLC-UV Method for the Simultaneous Determination of Repaglinide, Dexamethasone, and Remdesivir, and its Application to Synthetic Mixture and Human Plasma","authors":"Miglena Smerikarova, Stanislav Bozhanov, Alexandrina Mateeva, Vania Maslarska","doi":"10.2174/0115734129263384230928052923","DOIUrl":"https://doi.org/10.2174/0115734129263384230928052923","url":null,"abstract":"Background:: The onset of the COVID-19 pandemic caused numerous difficulties in the treatment of cardiovascular diseases and diabetes mellitus. A persistent risk of developing severe complications and increased mortality from the COVID-19 infection has been reported. In the clinical studies, patients receiving remdesivir and dexamethasone as COVID-19 combination therapy simultaneously with some type II diabetes therapeutic regimens had been reported to have a considerably better state and recover faster. Unfortunately, there is not enough information on the combination of meglitinides, remdesivir, and dexamethasone, and therefore, careful monitoring of the patients' everyday health condition is needed. Objectives:: The present study aimed to describe a high-performance liquid chromatographic method for the determination of repaglinide, dexamethasone, and remdesivir in laboratoryprepared mixtures and human plasma by UV detection. Methods:: Isocratic elution of the mobile phase (consisting of 0.1% trifluoroacetic acid in water and acetonitrile in the ratio 70:30 v/v) was set at a flow rate of 1.0 ml/min, and the developed analytical procedure has been found to be fast and simple. Chromatographic determination was performed on a Purospher® RP – 18 column at room temperature and a UV detector was set at 235 nm. result: The developed method was validated for linearity in the range 2-32 μg/ml. Calibration curves were linear over the selected range with correlation coefficients (R2) greater than 0.996. The coefficients of variation for intraday and interday assay were <2% and the recovery percentages from plasma ranged from 93.83 to 106.49%. Conclusion:: The developed effective and specific method can be applied in routine quality control and clinical laboratory practice.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135762585","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Analytical Methodologies for the Estimation of Acyclovir as Key Members of Anti-viral Agent: Two Decades in Review 评价阿昔洛韦作为抗病毒药物关键成员的分析方法:二十年回顾
4区 医学
Current Pharmaceutical Analysis Pub Date : 2023-10-01 DOI: 10.2174/1573412919666230908161943
Akhil Gupta, Shilpi Pathak
{"title":"Analytical Methodologies for the Estimation of Acyclovir as Key Members of Anti-viral Agent: Two Decades in Review","authors":"Akhil Gupta, Shilpi Pathak","doi":"10.2174/1573412919666230908161943","DOIUrl":"https://doi.org/10.2174/1573412919666230908161943","url":null,"abstract":"Abstract: Herpes simplex virus (HSV) is a viral infection that primarily targets oral and genital organs in humans. Acyclovir is a widely prescribed anti-viral agent used in the infection caused by herpes simplex virus (HSV). This article emphasizes several analytical techniques, including spectrophotometry, High-performance liquid chromatography, High-performance thin-layer liquid chromatography, Ultra performance liquid chromatography, and Liquid chromatography/Mass detection for the quantification of acyclovir in different matrices like biological fluids and Pharmaceutical formulation. In the proposed work, numerous methods for different techniques were extracted from various databases such as Science Direct, Springer, PubMed, SCOPUS, Web of Science, etc. According to the recommendation from the internal conference on harmonization, this review describes how to determine the presence of utilizing acyclovir in different analytical techniques alone or in combination with another drug.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135219495","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Application of the Different Analytical Methods for Non-chromophoric Pharmaceutical Compounds 非显色性药物化合物不同分析方法的应用
4区 医学
Current Pharmaceutical Analysis Pub Date : 2023-10-01 DOI: 10.2174/0115734129255201230925103348
Neha Singh, Sumit Pannu, Karanvir Singh, Md Jawaid Akhtar, Ankit Anchliya, Shah Alam Khan
{"title":"Application of the Different Analytical Methods for Non-chromophoric Pharmaceutical Compounds","authors":"Neha Singh, Sumit Pannu, Karanvir Singh, Md Jawaid Akhtar, Ankit Anchliya, Shah Alam Khan","doi":"10.2174/0115734129255201230925103348","DOIUrl":"https://doi.org/10.2174/0115734129255201230925103348","url":null,"abstract":"Abstract: The physicochemical properties of non-chromophoric compounds that lack a group to absorb UV-visible radiation make them difficult to analyze with a simple detector. Pharmaceutical formulations and their unknown impurities, which show weak or no response with a UV detector, remain undetected and pose a challenge to the analysis of these compounds. Direct measurement of a chromophore complex formed between the compound and the colored ions present in the electrolyte solution with UV detection is one of the validated methods to analyze non-chromophoric compounds. The derivatization with either chromophore or fluorescent group for the detection of the non-chromophoric compounds with HPLC-UV-Vis or fluorescence detector is also commonly used to study the physicochemical properties of the pharmaceutical formulations. The other techniques to analyze such non-chromophoric compounds include conductivity (ionic molecules), amperometry (molecules oxidized or reduced), mass spectrometry, evaporative light scattering detector (ELSD), condensation nucleation light scattering detector (CNLSD), capillary electrophoresis (CE), gas chromatography (GC), etc. This review covers various separation and detection techniques developed for the analysis of non-chromophoric compounds.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136198950","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Quality By Design (QbD): A Comprehensive Understanding and Implementation In Pharmaceuticals Development 质量设计(QbD):在药物开发中的全面理解和实施
4区 医学
Current Pharmaceutical Analysis Pub Date : 2023-09-14 DOI: 10.2174/1573412919666230914103355
Sarita S. Pawar, Yash S. Mahale, Prachi A. Kalamkar, Rohini A. Satdive, Sujata K. Sonawane, Sneha P. Bhapkar
{"title":"Quality By Design (QbD): A Comprehensive Understanding and Implementation In Pharmaceuticals Development","authors":"Sarita S. Pawar, Yash S. Mahale, Prachi A. Kalamkar, Rohini A. Satdive, Sujata K. Sonawane, Sneha P. Bhapkar","doi":"10.2174/1573412919666230914103355","DOIUrl":"https://doi.org/10.2174/1573412919666230914103355","url":null,"abstract":"Abstract: Quality by Design (QbD) is a systematic approach for improvement that stresses product and process and begins with a predetermined objective, as recommended by the USFDA and International Council Harmonization (ICH). Regulatory bodies frequently highlight the use of ICH quality criteria, which include Q8, Q9, Q10, and Q11. The differentiation between the traditional and QbD helps to study the risk assessment and technique for developing new products. There are a few steps involved in pharmaceutical and Analytical QbD. Various factors were used for the study of QbD, such as Analytical Target Product Profile (ATPP), Risk Assessment Quality Design Space, Control Strategy, etc. Critical Quality Attribute (CQA) may be understood and analyzed via a way of means of understanding the goods and technique and risk evaluation is useful for effective verbal exchange among FDA and industry, research/improvement and production, and amongst a couple of production sites inside the company. Life-cycle management of analytical procedure begins off evolving with the establishment of ATP and maintains until the approach is in use. The design of the experiment (DoE) involves the Q8 guidelines. DoE has been used in the rational development and optimization of analytical methods. Culture media composition, mobile phase composition, flow rate, and time of incubation are input factors (independent variables) that may be screened and optimized using DoE. Process analytical technology is implemented for the understanding and identification of developing a product and techniques. There are various benefits and applications of QbD in the pharmaceutical industry.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134970680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Novel “HYDALJSS08” Hydroalcoholic Polyherbal Formulation Development and Ultra-performance Liquid Chromatographic Separation,Estimation of Andrographolides in Andrographis Paniculata whole Plants and a Marketed Siddha-based Polyherbal Formulation “Kabusura Kudineer” 新型“HYDALJSS08”水醇多草药制剂的开发和超高效液相色谱分离、测定穿心莲全株中的穿心莲内酯和一种市场化的Siddha基多草药制剂“Kabusula Kudineer”
IF 0.6 4区 医学
Current Pharmaceutical Analysis Pub Date : 2023-09-01 DOI: 10.2174/1573412919666230901123904
Ramkishan Jatoth, S.P Dhanabal, V. Senthil, T. Ganesh, Jubie Selvaraj, M.R Jeyprakash, D. Basavan
{"title":"Novel “HYDALJSS08” Hydroalcoholic Polyherbal Formulation Development and Ultra-performance Liquid Chromatographic Separation,\u0000Estimation of Andrographolides in Andrographis Paniculata whole Plants and a Marketed Siddha-based Polyherbal Formulation “Kabusura Kudineer”","authors":"Ramkishan Jatoth, S.P Dhanabal, V. Senthil, T. Ganesh, Jubie Selvaraj, M.R Jeyprakash, D. Basavan","doi":"10.2174/1573412919666230901123904","DOIUrl":"https://doi.org/10.2174/1573412919666230901123904","url":null,"abstract":"\u0000\u0000The Siddha-based polyherbal formulation known as “Kabusura Kudineer (Marketed)\"\u0000and developed as “HYDALJSS08” hydroalcoholic polyherbal formulation contains some fifteen\u0000plant materials in a dried raw form. Due to its immuno-booster properties, the Ministry of Ayush, Govt of\u0000India, highly recommended the use of \"Kabusura Kudineer\" during the pandemic of COVID-19.\u0000\u0000\u0000\u0000The present study intends to expand and validate the analytical profile for Andrographolides\u0000(AP), and isolated Andrographolides (AP) from the Andrographis Paniculata whole plant\u0000and in the Polyherbal Formulations (Marketed-Kabusura Kudineer, & Developed “HYDALJSS08”).\u0000\u0000\u0000\u0000One of the active components of “Kabusura Kudineer” marketed and developed as\u0000“HYDALJSS08” Hydroalcoholic Polyherbal formulation is kalmegh, also known as the king of bitter\u0000(Andrographis Paniculata-Acanthaceae). Kalmegh composes active principal components of Andrographolides\u0000(AP), which are proven for their Anti-viral and immunomodulatory activity. The preliminary\u0000identification of AP and the sample was carried out by TLC and FT-IR. The liquid chromatography\u0000was performed on a Zorbaz SB C8 (250*4.6mm & 5μm). The mobile phase incorporated pH 2.8\u0000phosphate buffer with Acetonitrile: Methanol (60:30:10). The flow rate of the mobile phase was\u00001ml/min, and effluents were kept an eye on at 223 nm in a UV detector. The run time on the chromatogram\u0000was 10 min, and retention time was also observed.\u0000\u0000\u0000\u0000The Rf value of Andrographolides (AP) was found to be 0.62. ICH guidelines were followed\u0000to carry out the Validation parameter. The retention time of AP was 2.5 min, and the Valid parameters of\u0000AP and system precision were as follows: SD (1831.11), % RSD (0.2), regression equations y = 41978 +\u0000x−10763, and correlation coefficient (R2) 0.9994. The adequate Linearity concentration was found to be\u00005 to 50 μg/ml, the value of LODs was 0.61μg /ml, LOQs was 2.01 μg/ml, method precision % RSD was\u00000.2, SD was 1597.1, and recovery was 99.9% and 101%. AP content found in a formulation (“Kabusura\u0000Kudineer” 1.48 μg/mL, developed “HYDALJSS08” Hydroalcoholic Polyherbal formulation-0.48 μg/ml)\u0000and isolated Andrographolides from Andrographis paniculata was 112.4μg/ml.\u0000\u0000\u0000\u0000The developed HPLC methods enabled simple, novel, rapid, easy, accurate, reproducible,\u0000and linear analysis of isolated andrographolides, and Siddha-based Polyherbal formulations.\u0000","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44824280","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pharmacokinetics Study and Simultaneous Quantification of Eight Schisandra Lignans in Normal Rats by LC-MS/MS after Oral Administration of Schisandra Lignan Extract 五味子提取物在正常大鼠体内的药动学研究及LC-MS/MS同时定量
4区 医学
Current Pharmaceutical Analysis Pub Date : 2023-09-01 DOI: 10.2174/1573412919666230908105226
Yan Yu, Yongduo Yu, Zhenqi Wu, Shiyu Zhang
{"title":"Pharmacokinetics Study and Simultaneous Quantification of Eight Schisandra Lignans in Normal Rats by LC-MS/MS after Oral Administration of Schisandra Lignan Extract","authors":"Yan Yu, Yongduo Yu, Zhenqi Wu, Shiyu Zhang","doi":"10.2174/1573412919666230908105226","DOIUrl":"https://doi.org/10.2174/1573412919666230908105226","url":null,"abstract":"Background: Schisandra chinensis has been widely used. It has many pharmacological activities. Lignans, including schizandrol A, schizandrin A, schisandrin B, schisanhenol, gomisin E, gomisin H, gomisin J, gomisin N, etc., are the major active ingredients of Schisandra chinensis. Objective: In the present study, the liquid chromatography-tandem mass spectrometric (LC-MS/MS) method was developed for the simultaneous quantification of Schisandra lignans in normal rats. Methods: Nifedipine was used as an internal standard, and chromatographic separation was achieved on Agela Venusil C18 Plus (4.6*100mm, 3μm). Aqueous solution containing 0.1% (v/v) formic acid was used as the mobile phase A, and methanol solution containing 0.1% (v/v) formic acid was used as the mobile phase B for gradient elution. The flow rate was 0.8 mL/min. Multiple reaction monitoring (MRM) mode with positive electrospray ionization was used to detect the analytes. Results: The calibration curves provided reliable responses at concentrations of 0.5-200 ng/ml for schizandrin A, schisandrin B, schisanhenol, gomisin E, gomisin H, gomisin N, concentrations of 10-200 ng/ml for schizandrol A, and concentrations of 5-200 ng/ml for gomisin J. The inter- and intra-day coefficients of variations (CVs) for the precision ranged from 6.70% (3.44%) to 11.66% (10.38%). The inter- and intra-day accuracies of eight lignans ranged from 95.70% (93.89%) to 104.59% (106.13%). No significant variation of any of the lignans occurred in the stability tests. Conclusion: The established method can be successfully applied to the pharmacokinetic study of the Schisandra lignan extract in normal rats.","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135249082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Diagnostic Tool for Good Chromatographic Practices Applied to HPLC in Pharmaceutical Quality Control 一种用于药品质量控制的HPLC良好色谱规范诊断工具
IF 0.6 4区 医学
Current Pharmaceutical Analysis Pub Date : 2023-08-23 DOI: 10.2174/1573412919666230823140503
Rodolpho Guilherme Menezes Gama, Aline de Souza Ramos, A. Amaral
{"title":"A Diagnostic Tool for Good Chromatographic Practices Applied to HPLC in Pharmaceutical Quality Control","authors":"Rodolpho Guilherme Menezes Gama, Aline de Souza Ramos, A. Amaral","doi":"10.2174/1573412919666230823140503","DOIUrl":"https://doi.org/10.2174/1573412919666230823140503","url":null,"abstract":"\u0000\u0000High-performance liquid chromatography is one of the most used analytical techniques in quality control in the pharmaceutical industry. Since it is a complex technique, it needs good practices that can contribute to compliance with regulatory requirements.\u0000\u0000\u0000\u0000This study aims to establish a diagnostic tool for Good Chromatographic Practices (GCP) for the self-assessment of a Quality Control Laboratory (QCL).\u0000\u0000\u0000\u0000The research was carried out on scientific bases, pharmaceutical legislation, as well as guides published by manufacturers.\u0000\u0000\u0000\u0000Seven axes of action were identified: implementation, management, and continuous improvement of GCP in the laboratory; GCP in the installation, operationalization, qualification, and validation processes of the equipment and software; GCP in processes related to data management, including guidelines regarding access, generation, integrity, and traceability; GCP related to the management and use of consumables; GCP related to handling, maintenance, analytical and operational troubleshooting; GCP in the processes of preparation, use, and storage of analytical solutions and reagent solutions; and GCP related to the acquisition and processing of standards, samples, and results. These axes resulted in a diagnostic tool with 124 questions.\u0000\u0000\u0000\u0000The application of the GCP diagnostic tool provides the mapping of the routine and procedures related to the execution of the HPLC technique for quality control in the pharmaceutical industry, contributing to meeting regulatory requirements.\u0000","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2023-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42999475","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Application of a Quantitative Proton Nuclear Magnetic Resonance Method for the Determination of Protopine in Radix Dactylicapnotis 质子核磁共振定量法测定丁香中丙氨酸的含量
IF 0.6 4区 医学
Current Pharmaceutical Analysis Pub Date : 2023-08-23 DOI: 10.2174/1573412919666230823144117
Xue-Jiao Li, Jianwei Dong, Zheng-Fen Liu, Jun-You Shi, Fengmei Zhang, Yan Fa, Ya-Li Li, Xue-Xian Wang
{"title":"Application of a Quantitative Proton Nuclear Magnetic Resonance Method for the Determination of Protopine in Radix Dactylicapnotis","authors":"Xue-Jiao Li, Jianwei Dong, Zheng-Fen Liu, Jun-You Shi, Fengmei Zhang, Yan Fa, Ya-Li Li, Xue-Xian Wang","doi":"10.2174/1573412919666230823144117","DOIUrl":"https://doi.org/10.2174/1573412919666230823144117","url":null,"abstract":"\u0000\u0000The Bai ethnologic herb Radix Dactylicapnotis, the root and tuber of Dactylicapnos scandens (Papaveraceae), is used for clearing heat, relieving pain, and achieving hemostasis and antihypertensive effects.\u0000\u0000\u0000\u0000The study aimed to develop a quantitative method for determining the protopine content in Radix Dactylicapnotis by using proton nuclear magnetic resonance (1H NMR) spectroscopy.\u0000\u0000\u0000\u0000The deuterium solvent, internal standard, and NMR parameters were optimized. The quantitative method was validated by linearity, precision, accuracy, repeatability, and stability, as well as limit-of-detection (LOD) and limit-of-quantitation (LOQ) assays.\u0000\u0000\u0000\u0000A mixture solution consisting of 500 μL of DMSO-d6 and 20 μL of D2O enabled satisfactory separation of the signals to be integrated into the 1H NMR spectrum. Trimethyl benzene-1,3,5-tricarboxylate (TMBT) was selected as an internal standard. The integration of δ 6.05–6.08 corresponding to OCH2O was selected to quantify protopine. The developed quantitative method was found to be precise and accurate and to exhibit excellent linearity and range. The protopine content in Radix Dactylicapnotis could be quantified accurately using the featured signal.\u0000\u0000\u0000\u0000This is the first study to report quantitative 1H NMR determination of protopine in Radix Dactylicapnotis. The study results indicate that quantitative 1H NMR represents a feasible alternative to HPLC-based methods for the quantitation of protopine in Radix Dactylicapnotis, and is suitable for the quality control of Radix Dactylicapnotis.\u0000","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2023-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46281986","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Development and Validation of In-vitro Release Study of Molnupiravir Capsules by RP-HPLC 反相高效液相色谱法研究莫那匹韦胶囊体外释放度
IF 0.6 4区 医学
Current Pharmaceutical Analysis Pub Date : 2023-08-21 DOI: 10.2174/1573412919666230821102105
V. Patil, S. Singhal, Aman Sharma, Anirudh Malik, M. Dahiya, Gaurav Singh, S. kaushik
{"title":"Development and Validation of In-vitro Release Study of Molnupiravir Capsules by RP-HPLC","authors":"V. Patil, S. Singhal, Aman Sharma, Anirudh Malik, M. Dahiya, Gaurav Singh, S. kaushik","doi":"10.2174/1573412919666230821102105","DOIUrl":"https://doi.org/10.2174/1573412919666230821102105","url":null,"abstract":"\u0000\u0000The coronavirus disease-2019 (COVID-19) outbreak all over the world has led researchers to strive to develop treatment and preventive measures to control its progression.\u0000\u0000\u0000\u0000Molnupiravir, a prodrug of the synthetic nucleoside derivative N-4-hydroxycytidine was found to be a promising candidate against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).\u0000\u0000\u0000\u0000Result: It could significantly reduce the risk of hospitalization and mortality among patients with positive SARS-CoV-2 reports. In this study, an RP-HPLC method with UV detection was developed to determine its dissolution and release in the capsule dosage form. The developed method was validated as per International Council for Harmonization (ICH) guidelines.\u0000\u0000\u0000\u0000The method was evaluated and validated for its applicability using various parameters. It was found to be a simple, rapid, selective, sensitive, accurate, precise, robust and rugged method.\u0000","PeriodicalId":10889,"journal":{"name":"Current Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.6,"publicationDate":"2023-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47402107","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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