ABSTRACT

A simple, economic, selective and precise RP-HPLC method has been developed and validated for the estimation of related impurities of Metformin HCl and Canagliflozin in combined tablet. RP-HPLC method with gradient elution analysis was performed on Hypersil BDS C18 column (250mm X 4.6mm, 5?m) using mobile phase 0.05M Potassium Dihydrogen Phosphate buffer pH-5.0 and Acetonitrile in the ratio of (70: 30 v/v) at a flow rate of 1.0 ml/min and the detection wavelength was 290nm. The analytical method is validated according to ICH guidelines. The linearity was observed in the range of LOQ-15.0?g/ml for Metformin HCl and its related impurity A. Similarly the linearity was observed in the range of LOQ-7.5?g/ml for Canagliflozin and its related Impurity 2. The correlation coefficient was observed NLT than 0.99 for all the analyte. The % recovery value was found minimum of 98.128% and maximum of 101.996% for Metformin HCl Impurity A. Similarly the % recovery value was found minimum of 98.472% and maximum of 101.150% for Canagliflozin Impurity 2. The % recovery values observed between the range of 98.128% to 101.996% for Metformin Impurity A and 98.472% to 101.150% for Canagliflozin Impurity 2. The LOD value was found 0.495?g/ml for Metformin HCl and 0.098?g/ml for its related impurity A. The LOD value was found 0.248?g/ml for Canagliflozin and 0.050?g/ml for its related Impurity 2. The LOQ value was found 1.500?g/ml for Metformin HCl and 0.297?g/ml for its related impurity A. The LOQ value was found 0.753?g/ml for Canagliflozin and 0.151?g/ml for its related Impurity 2. The results indicate that the developed method is accurate, precise, simple and rapid. Keywords: Stability-indicating RP-HPLC; Metformin HCl; Canagliflozin; ICH guidelines; related substance; and validation
Publication date: 01/01/2024

https://ijbpas.com/pdf/2024/January/MS_IJBPAS_2024_7717.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.1.7717