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

IF 1.9 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS Bioanalysis 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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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

Bioanalysis BIOCHEMICAL RESEARCH METHODS-CHEMISTRY, ANALYTICAL

CiteScore

3.30

自引率

16.70%

发文量

审稿时长

2 months

期刊介绍： Reliable data obtained from selective, sensitive and reproducible analysis of xenobiotics and biotics in biological samples is a fundamental and crucial part of every successful drug development program. The same principles can also apply to many other areas of research such as forensic science, toxicology and sports doping testing. The bioanalytical field incorporates sophisticated techniques linking sample preparation and advanced separations with MS and NMR detection systems, automation and robotics. Standards set by regulatory bodies regarding method development and validation increasingly define the boundaries between speed and quality. Bioanalysis is a progressive discipline for which the future holds many exciting opportunities to further reduce sample volumes, analysis cost and environmental impact, as well as to improve sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling and processing. The journal Bioanalysis focuses on the techniques and methods used for the detection or quantitative study of analytes in human or animal biological samples. Bioanalysis encourages the submission of articles describing forward-looking applications, including biosensors, microfluidics, miniaturized analytical devices, and new hyphenated and multi-dimensional techniques. Bioanalysis delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for the modern bioanalyst.