五种简便紫外分光光度法测定安格列汀原料药和内服片剂含量的建立与验证

A. Patil, A. Shirkhedkar
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引用次数: 3

摘要

阿格列汀是一种用于治疗糖尿病的二肽基肽酶-4 (DPP-4)抑制剂。建立了5种简便、特异、灵敏、快速、经济的紫外分光光度法测定安格列汀原料片和内置片的含量。考虑光谱的振幅和曲线下面积,建立了基于零阶、一阶和二阶导数分光光度法的五种紫外分光光度法。5种方法中阿格列汀浓度在2 ~ 8 μg/mL范围内均符合线性关系,相关系数(r2>0.999)。在开发的方法中估计的药物量的百分比被发现与内部片剂配方的标签声明很好地一致。所有方法均按照国际协调会议(ICH)指南进行验证。结果表明,所提出的方法是线性的、准确的、精确的、坚固的,并且具有足够的灵敏度。关键词:阿格列汀,紫外光谱法,曲线下面积法,导数光谱法,验证
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and Validation of Five Simple UV-Spectrophotometry Methods for Estimation of Anagliptin in Bulk and in-house Tablets
Anagliptin is a Dipeptidyl peptidase-4 (DPP-4) inhibitor used in the treatment of diabetes. Five simple, specific, sensitive, rapid and economical UV- Spectrophotometry methods have been established for the determination of Anagliptin in bulk and in-house tablets. All five methods of UVSpectrophotometry based upon Zero Order, First Order and Second Order derivative Spectrophotometry have been established considering amplitude and Area under Curve of the spectrum. In all five methods, Anagliptin obeyed linearity in the concentration range of 2-8 μg/mL with correlation coefficient (r2>0.999). The % amount of drug estimated in the developed methods was found to be good agreement with label claimed in in-house tablet formulation. All the methods were validated as per International conference on Harmonization (ICH) guidelines. All these proposed methods were proved to be linear, accurate, precise and rugged and also adequately sensitive. Key words: Anagliptin, UV-spectro photometry, Area Under Curve technique, Derivative Spectro photometry, Validation.
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