Simultaneous estimation of canagliflozin and metformin hydrochloride in tablet dosage form by UV spectrophotometry

D. Sharmila, J. Chandini, K. Lakshmi, C. Balaji, A. Rao
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引用次数: 1

Abstract

The combination of Canagliflozin and Metformin was available as fixed dose tablets for the treatment of type 2 diabetes. The present method aims to develop a simple, precise and accurate spectrophotometric method for simultaneous determination of Canagliflozin and Metformin in commercial formulation. The method utilizes Vierordt’s equation based on the measurement at two wavelengths 290nm (?max of Canagliflozin) and 236nm (?max of Metformin). The method exhibited linear range of 2.5 to 15µg/ml and 5 to 17.5µg/ml for Canagliflozin and Metformin, respectively, with a correlation coefficient of 0.999. The LOD and LOQ for Canagliflozin were found to be 0.43 and 1.31 respectively. For Metformin the LOD and LOQ were found to be 0.49 and 1.49 respectively. The recovery of Canagliflozin and Metformin were found to be 99.43 and 98.82 respectively. The results were validated statistically as per ICH guidelines and were found to be satisfactory. To conclude, the developed UV spectrophotometric method is more economical for analysis of Canagliflozin and Metformin in both bulk and pharmaceutical dosage form for routine analysis. Keywords: Canagliflozin, Metformin, Vierordt’s equation, UV-Spectrophotometry, ICH guidelines
紫外分光光度法测定片剂剂型中卡格列净和盐酸二甲双胍的含量
卡格列净联合二甲双胍作为固定剂量片剂可用于治疗2型糖尿病。本方法旨在建立一种简便、精确、准确的同时测定商业制剂中加格列净和二甲双胍含量的分光光度法。该方法基于两个波长290nm (?Canagliflozin的max)和236nm (?二甲双胍的最大值)。加格列净和二甲双胍在2.5 ~ 15µg/ml和5 ~ 17.5µg/ml范围内呈线性关系,相关系数为0.999。卡格列净的LOD和LOQ分别为0.43和1.31。二甲双胍的LOD和LOQ分别为0.49和1.49。加格列净和二甲双胍的回收率分别为99.43和98.82。根据ICH指南对结果进行了统计验证,结果令人满意。综上所述,所建立的紫外分光光度法对加格列净和二甲双胍的原料药和常规药剂型的分析更为经济。关键词:卡格列净,二甲双胍,Vierordt方程,紫外分光光度法,ICH指南
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