Abstract
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF CANAGLIFLOZIN AND METFORMIN IN DRUG PRODUCT BY RP-HPLC

Uppalapati Jyothi and Parimi Umadevi*

ABSTRACT

The purpose of the research is to develop a simple, precise, economical, accurate, reproducible, and sensitive method for the estimation of of Metformin and Canagliflozin drug product by rp-hplc method. The chromatographic separation was achieved on C18 column (Inertsil ODS 3V C18 250*4.6mm) at ambient temperature .The separation achieved employing a mobile phase consists of 0.1%v/v TFA in water: Acetonitrile (20:80). The flow rate was 1.0ml/minute and ultra violet detector at 254nm. The average retention time for Metformin and Sacubitil found to be 2.32 min and 4.20 min. the proposed method was validated for selectivity, precision, linearity and accuracy. All validation parameters were within the acceptable range. The assay methods were found to be linear from 200.0 – 600.0μg/ml for Metformin and 20.0 – 60.0μg/ml of Canagliflozin.

Keywords: Metformin and Canagliflozin, Isocratic, HPLC, Inertsil ODS, TFA, Acetonitrile, Methanol and validation.


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