使用五种不同的有效分析方法对尼日利亚市场上销售的一些盐酸莫西沙星片剂品牌进行比较评估

E. A. Omotoso, E. B. Unaji
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引用次数: 0

摘要

背景:药品检测是质量控制的一个重要方面。有必要比较任何药物的仿制品牌与创新/比较品牌的生物等效性,因为这构成了比较其治疗等效性的基础:本研究旨在通过使用五种不同的验证分析方法,确定尼日利亚市场上盐酸莫西沙星片剂(MOX-HCl)品牌的最准确检测方法,并验证其互换性:本研究涉及三个品牌的 MOX-HCl,包括对比品牌 Moxiget®。研究涉及质量控制测试,包括:重量均匀性、直径、厚度、易碎性、硬度、崩解度、溶解度和活性成分含量(检测)方法,包括:磷酸盐缓冲紫外可见分光光度法、紫外分光光度法、动力学分光光度法、比色法和氧化还原反应法:本研究使用的所有样品都通过了质量控制测试,因此质量达标,具有药学等效性:因此,本研究得出结论:磷酸盐缓冲紫外可见分光光度法是检测莫西沙星片剂最准确的方法,比色法可作为莫西沙星检测首选方法的替代方法,本研究中检测的三种样品可与比较品牌(莫西格特®)互换。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparative evaluation of some moxifloxacin hydrochloride tablet brands marketed in Nigeria using five different validated analytical methods
Background: Assay of pharmaceuticals is an important aspect of quality control. It is necessary to compare the bioequivalence of generic brands of the any drug to an innovator/comparator brand as this forms the basis for comparing their therapeutic equivalence.Objective: This study aimed to determine the most accurate method for the assay of moxifloxacin hydrochloride (MOX-HCl) tablet brands in Nigerian markets by using five different validated analytical methods and also verify their interchangeability.Material & Methods: This study involved three brands of MOX-HCl including the comparator brand, Moxiget®. The study involves both quality control tests including: weight uniformity, diameter, thickness, friability, hardness, disintegration, dissolution and content of active ingredient (assay) methods including: phosphate buffered UV-Vis spectrophotometric, UV spectrophotometric, kinetic spectrophotometric, colorimetry and utilization of oxidation-reduction reaction methods.Results: All the samples used for this study passed the quality control tests and thus were of standard quality and therefore pharmaceutically equivalent.Conclusion: This study therefore conclude that phosphate buffered UV-Vis spectrophotometry provide the most accurate method to assay Moxifloxacin tablet, colorimetry assay method can serve as a substitute to the preferred method for the moxifloxacin assay and the three samples assayed in this work are interchangeable with the comparator brand (Moxiget®).
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