稳定性指示RP-HPLC方法的建立和验证,用于同时估计Grazoprevir和Elbasvir的散装和药物剂型

V. P. Kumar, A. Kumar, B. Sivagami, R. C. Kumar, M. Babu
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引用次数: 3

摘要

建立了Grazoprevir和Elbasvir片剂同时测定的简便、准确、精确的方法。色谱通过Kromosil C18 (250 × 4.6 mm), 5m。流动相含缓冲液:以45:55的比例取乙腈,以1ml /min的流速泵入柱中。本方法使用的缓冲液为磷酸二氢钾。温度保持在30°C。优选波长为215 nm。Elbasvir和Grazoprevir的滞留时间分别为2.503 min和3.004 min。Elbasvir和Grazoprevir的RSD分别为0.3和0.4。Grazoprevir和Elbasvir的回收率分别为98.17%和99.83%。回归方程得出Grazoprevir和Elbasvir的LOD、LOQ分别为0.24、0.73和0.06、0.19。该方法减少了滞留时间,缩短了运行时间,简便、经济,可用于工业中常规的质量控制试验。
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Stability indicating RP-HPLC method development and validation for the simultaneous estimation of Grazoprevir and Elbasvir in bulk and pharmaceutical dosage form
A simple, Accurate and precise method was developed for the simultaneous estimation of the Grazoprevir and Elbasvir in Tablet dosage form. Chromatogram was run through Kromosil C18 (250 x 4.6 mm), 5m. Mobile phase containing Buffer: Acetonitrile taken in the ratio 45:55 was pumped through column at a flow rate of 1 ml/min. Buffer used in this method was Di Potassium Hydrogen ortho Phosphate. Temperature was maintained at 30°C. Optimized wavelength selected was 215 nm. Retention time of Elbasvir and Grazoprevir and were found to be 2.503 min and 3.004. %RSD of the Elbasvir and Grazoprevir were and found to be 0.3 and 0.4 respectively. %Recovery was obtained as 98.17% and 99.83% for Grazoprevir and Elbasvir respectively. LOD, LOQ values obtained from regression equations of Grazoprevir and Elbasvir were 0.24, 0.73 and 0.06, 0.19 respectively. Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.
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