Method Development And Validation For The Simultaneous Estimation Of Remdesivir In Bulk And Pharmaceutical Dosage Form And Stability Studies By Uplc

Q3 Pharmacology, Toxicology and Pharmaceutics

Journal of Pharmaceutical Negative Results Pub Date : 2022-12-31 DOI:10.47750/pnr.2022.13.s07.928

Mohammed Azeemuddin , Hemant Kumar Sharma

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Abstract

An Easy, sensitive, specific and precise UPLC method for the pharmaceutical dose estimation of Remdesivir in tablet dosage form. Chromatogram was run through BEH (2.1 x 50mm, 1.7µm) Mobile phase containing 0.01N Kh2po4: Acetonitrile taken in the ratio 60:40 was pumped through column at a flow rate of 0.3ml/min. Buffer used in this method was 0.01N Potassium dihydrogen phosphate buffer. Temperature was maintained at 30°C. Optimized wavelength selected was 252.0nm. Retention time of Remdesivir were found to be 1.565 min. %RSD of the Remdesivir were and found to be 0.3. %RSD of Repeatably precision of Remdesivir were found to be 0.3. %Recovery was obtained as 99.87% for Remdesivir. %Assay was obtained as 99.58% for Remdesivir. LOD, LOQ values obtained from regression equation of Remdesivir were 0.33, 1.00. Regression equation of Remdesivir is y = 22602x + 1936. 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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瑞德西韦原料药和制剂剂型同时测定方法的建立与验证及Uplc稳定性研究

一种简便、灵敏、特异、精确的超高效液相色谱法估算雷德西韦片剂剂量。色谱通过BEH (2.1 × 50mm, 1.7µm)流动相含有0.01N Kh2po4:以60:40的比例取乙腈以0.3ml/min的流速泵入柱中。本方法所用缓冲液为0.01N磷酸二氢钾缓冲液。温度保持在30°C。优选波长为252.0nm。瑞姆德西韦的保留时间为1.565 min, RSD为0.3。瑞德西韦重复性精密度的%RSD为0.3。瑞德西韦的回收率为99.87%。瑞德西韦的检测率为99.58%。由回归方程得到的LOD、LOQ值分别为0.33、1.00。瑞德西韦的回归方程为y = 22602x + 1936。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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Journal of Pharmaceutical Negative Results PHARMACOLOGY & PHARMACY-

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