Stability indicating liquid chromatographic method for the estimation of remogliflozin etabonate

IF 1.8 Q3 CHEMISTRY, ANALYTICAL Journal of Chemical Metrology Pub Date : 2020-12-01 DOI:10.25135/jcm.46.20.07.1734
D. Shah, Ishita I. Gondalia, V. Patel, Ashok Mahajan, U. Chhalotiya
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引用次数: 16

Abstract

: Accurate and precise reverse phase liquid chromatographic method has been developed for the estimation Remogliflozin etabonate in bulk and tablet dosage form. Reverse phase C18 column was used as stationary phase along with mixture of methanol:water (70:30%, v/v) as a mobile phase. Mobile phase flow rate was maintained at 1mL/min and analysis was performed at 229 nm. The method was linear in the concentration range of 1 – 25 μg/mL with correlation coefficient (r 2 ) 0.997. The proposed method was validated with respect to linearity, accuracy, precision and robustness as per ICH Q2 (R1) guideline. To find out the possible degradation pathway, forced degradation studies were performed. The degraded product peaks were well resolved from the pure drug peak with significant difference in their retention time value. The drug was found to be highly susceptible to acid and base hydrolysis. The developed method can be used for analysis of stability samples and routing quality control evaluation of Remogliflozin etabonate in
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稳定性指示的液相色谱法测定瑞格列净的含量
建立了准确、精确的反相液相色谱法测定安他巴酸雷莫列净散装剂型和片剂剂型的含量。以反相C18柱为固定相,甲醇:水(70:30%,v/v)为流动相。流动相流速保持在1mL/min,在229 nm进行分析。该方法在1 ~ 25 μg/mL浓度范围内线性良好,相关系数(r 2) 0.997。根据ICH Q2 (R1)指南对该方法进行了线性、准确度、精密度和鲁棒性验证。为了找出可能的降解途径,进行了强制降解研究。降解产物峰与纯药峰分离较好,保留时间差异显著。这种药物被发现对酸碱水解非常敏感。该方法可用于盐酸雷莫列净的稳定性样品分析和路线质量控制评价
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来源期刊
Journal of Chemical Metrology
Journal of Chemical Metrology CHEMISTRY, ANALYTICAL-
CiteScore
2.30
自引率
15.40%
发文量
7
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