Analytical method of development and validation for determination of Canagliflozin and Metformin in API and synthetic mixture by RP-HPLC

Abstract

Listen

Translate article

There is a newly developed formulation for the management of the Diabetes is Combination of Canagliflozin with Metformin. As a result, an attempt was made to create and validate a simple, precise, accurate, and reproducible RP-HPLC technique for determining Canagliflozin and Metformin in a binary mixture, which was validated in accordance with ICH Q2 (R1). The mobile phase consisted of Acetonitrile: Phosphate Buffer (pH 3.5 ± 0.01) (70:30 v/v), and the Chromatogram was obtained at 254 nm for the separation of the two compounds. The retention times for Canagliflozin and Metformin were 2.2 min and 4.2 min respectively. The linearity was seen in the concentration range of 15–40 μg/ml and 10-30 μg/ml with co-efficient of correlation, r2 = 0.9997and r2 = 0.9998 for Canagliflozin and Metformin, respectively. The Active Content of Canagliflozin and Metformin determined in the Binary combination from the suggested approach were 99.43% for Canagliflozin and 99.59% for Metformin after completing the Assay. Canagliflozin's LOD and LOQ values were 0.3433 µg/ml and 1.0421 µg/ml, while Metformin's were 0.5927 µg/ml and 1.7962 µg/ml. The discovered method was used to synthetic formulations for the specific identification of Canagliflozin and Metformin.