RP-HPLC法同时测定达若那韦和利托那韦的分析方法建立及验证

Pasala Lydia Grace, C. Parthiban
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引用次数: 0

摘要

建立了一种简便、准确、精确的同时测定片剂中达那韦和利托那韦含量的方法。通过标准对称C18 (4.6 x 150 mm, 5m)运行色谱图。流动相含缓冲液0.01N KH2PO4:乙腈,比例为45:55%v/v,以1ml/min的流速泵入柱中。优选波长为290 nm。达那韦和利托那韦的滞留时间分别为2.131 min和2.593 min, RSD分别为0.8和0.6。达那韦和利托那韦的回收率分别为99.59%和99.94%。达若那韦和利托那韦的LOD、LOQ分别为0.86、2.60和0.09、0.29。达那韦的回归方程为y = 12533x + 10387,利托那韦的回归方程为y = 9061x + 183.8。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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Analytical method development and validation for the simultaneous estimation of Darunavir and Ritonavir by RP-HPLC method
A simple, Accurate, precise method was developed for the simultaneous estimation of the Darunavir and Ritonavir in tablet dosage form. Chromatogram was run through standard symmetry C18 (4.6 x 150 mm, 5m). Mobile phase containing Buffer 0.01N KH2PO4: Acetonitrile taken in the ratio 45:55%v/v was pumped through column at a flow rate of 1ml/min. Optimized wavelength selected was 290 nm. Retention time of Darunavir and Ritonavir were found to be 2.131 min and 2.593 min. %RSD of the Darunavir and Ritonavir were and found to be 0.8 and 0.6 respectively. %Recovery was obtained as 99.59% and 99.94% for Darunavir and Ritonavir respectively. LOD, LOQ values obtained from regression equations of Darunavir and Ritonavir were 0.86, 2.60 and 0.09, 0.29 respectively. Regression equation of Darunavir is y = 12533x + 10387 and y = 9061x + 183.8 of Ritonavir. Retention times were decreased and that 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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