分光光度法测定制剂和原料药中胆碱的含量及验证

Afnaz Jahan, Mohamed Khaleel, Husnain Fathima
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引用次数: 0

摘要

建立了一种简单、灵敏、准确、快速、经济的分光光度法测定和验证纯药和片剂剂型中比拉斯汀的方法。以甲醇为溶剂体系,在226.2nm处测定吸光度。在2 ~ 12µg/ml浓度范围内符合比尔定律,相关系数(r2)为0.9993。检测限(LOD)为1.224µg/ml,定量限(LOQ)为4.088µg/ml。所提出的分析方法根据ICH指南进行了验证,在范围、线性、精密度、准确度、稳健性和耐用性方面取得了良好的结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Estimation and Validation of Bilastine in Pharmaceutical Dosage Form and in Bulk Drug by Spectrophotometric Method
A simple, sensitive, accurate, rapid and economical Spectrophotometric method was developed for estimation and validation of Bilastine in pure drug and tablet dosage form. The absorbance was measured at 226.2nm using Methanol as solvent system. It obeyed Beer’s law at the concentration range of 2-12µg/ml with coefficient of correlation (r2) of 0.9993. Limit of detection (LOD) was found to be 1.224µg/ml and Limit of quantitation (LOQ) was found to be 4.088µg/ml. The proposed analytical method was validated according to ICH guidelines, yielded good results concerning range, linearity, precision, accuracy, robustness and ruggedness.
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