稳定性指示分光光度法测定原料药和制剂中盐酸米纳西普兰和盐酸度洛西汀的含量

M. Ghany, O. Abdel-Aziz, N. Fares, Eman Wafik Eskander
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引用次数: 0

摘要

本研究描述了准确灵敏的稳定性指示分光光度法测定盐酸米那西普兰在其酸、碱降解和盐酸度洛西汀在其碱降解存在下的含量;包括双波长、比差和比导数技术。根据国际协调会议(ICH)指南对开发的方法进行了验证。盐酸米那西普兰和盐酸度洛西汀的回收率分别为99.42 ~ 100.42%和100.17 ~ 100.3%。精密度结果的低相对标准偏差证实了所提出的方法对纯形式、实验室制备的混合物和药物制剂的估计的适用性。将所提出的方法与已报道的方法进行统计比较,发现所采用技术的准确度和精密度没有显著差异。验证研究表明,该方法简便、特异、快速,可用于盐酸米尔纳西普兰和盐酸度洛西汀的测定。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Stability-Indicating Spectrophotometric Methods for Determination of Milnacipran HCl and Duloxetine HCl in Bulk Drug and Pharmaceutical Formulations
The present study describes accurate and sensitive stability-indicating spectrophotometric methods for the determination of Milnacipran HCl in presence of its acid, base degradates, and Duloxetine HCl in presence of its base degradates; including Dual-wavelength, Ratio difference, and Ratio derivative techniques. The developed methods were validated according to the International Conference on Harmonisation (ICH) guidelines. The recovery percentage of Milnacipran HCl and Duloxetine HCl were found to be in the ranges 99.42-100.42% and 100.17-100.3%, respectively. The low relative standard deviation of precision results confirms the suitability of the proposed methods for the estimation of the studied drugs in pure form, laboratory-prepared mixtures, and pharmaceutical formulations. Statistical comparison of the proposed methods with the reported methods revealed that there were no significant differences concerning the accuracy and precision of the adopted techniques. Validation studies demonstrated that the proposed methods are easy, specific, and rapid for the determination of Milnacipran HCl and Duloxetine HCl.
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