An accurate, precise, specific modified HPLC method was developed for the simultaneous quantification of canagliflozine and metformin in bulk and dosage forms. A C18 column (250 x 4.6mm; 5 µm Phenomenex) with mobile phase containing 0.05% v/v triethylamine (pH6.5): acetonitrile (45:55% v/v) 200C was used and isocratic pump is used for elution and eluents were monitored at 215 nm. The retention times of canagliflozine and metformin were 3.4 min and 12.7 min respectively and showed a good linearity in the concentration range of 40-200 µg/mL of canagliflozine have found correlation coefficient of 0.999 and 10- 50 µg/mL of metformin with a correlation coefficient of 0.998. The average percent recoveries were found to be 98.60% and 98.90% respectively for canagliflozine and metformin.The developed method fallows all the validation parameters like accuracy, precision, linearity, limit of detection, limit of quantitation and solution stability. The proposed method was validated as per ICH guidelines and successfully applied to the simultaneous estimation of canagliflozine and metformin in bulk and dosage form.
Keywords: Canagliflozine, Metformin, Simultaneous Estimation, Phenomenax C18 Column, RP-HPLC, PDA Detection, Validation.
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