In vitro dissolution equivalence of Jordanian sildenafil generics via validated, stability-indicating HPLC method.

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2024-01-01 Epub Date: 2024-03-18 DOI:10.4155/bio-2023-0257

Hamdi Nsairat, Ali Al-Samydai, Mohamed El-Tanani, Ashok K Shakya, Somaya Ahmad, Shorouq Alsotari, Walhan Alshaer, Ammar Shanneir, Munib M Saket, Tawfiq A Arafat

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引用次数: 0

Abstract

This study was conducted to compare dissolution profiles of four Jordanian registered sildenafil (SDF) products to the originator. Dissolution samples were analyzed utilizing a validated and stability-indicating HPLC method in human plasma. Validation was performed for specificity, linearity, limit of detection, lower limit of quantification, precision, trueness and stability. SDF was extracted from plasma samples using liquid-liquid extraction. The analysis was performed utilizing isocratic elution on C18 column with 1.0 ml/min flow rate. The regression value was ∼0.999 over 3 days with drug recovery between 86.6 to 89.8%with 10 ng/ml lower limit of quantitation. This method displayed a good selectivity of SDF with improved stability under various conditions. The method was used for SDF quantification in dissolution medium. Similarity factors for local products varied according to the used mediums, but all SDF local products passed the dissolution in vitro test since all of them showed a released of >85% after 60 min at the dissolution mediums.

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通过经过验证的稳定性指示高效液相色谱法测定约旦西地那非仿制药的体外溶出度等效性。

本研究旨在比较四种在约旦注册的西地那非（SDF）产品与原研药的溶出特性。溶出度样品采用经过验证的稳定指示型高效液相色谱法在人体血浆中进行分析。对特异性、线性、检测限、定量下限、精密度、真实性和稳定性进行了验证。采用液液萃取法从血浆样品中提取 SDF。采用 C18 色谱柱进行等度洗脱，流速为 1.0 ml/min。3天的回归系数为0.999，药物回收率为86.6%至89.8%，定量下限为10纳克/毫升。该方法对SDF具有良好的选择性,在各种条件下的稳定性较好。该方法用于溶解培养基中SDF的定量分析。根据所用介质的不同，局部产品的相似系数也不同，但所有SDF局部产品都通过了体外溶出试验，因为所有产品在溶出介质中60分钟后的释放率均大于85%。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.