Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN AND ALOGLIPTIN IN BULK AND COMBINED TABLET DOSAGE FORM

*Kalyani Gudadhe, Bhagyashri Borade, Neha Deshmukh Mukund Tawar and Sagar Wankhade

ABSTRACT

A rapid, sensitive and accurate method for simultaneous estimation of Metformin and Alogliptin in drug product by liquid chromatography. The chromatographic separation was achieved on C18(ymc) (250X4.6mm,5.0).The separation achieved employing a mobile phase consists of 70%Methanol: 30%Water (0.1%OPA). The flow rate was 0.7ml/ minute and ultraviolet detector range at 250nm. The average retention time for Metformin and Alogliptin was found to be 4.279min and 6.023 min. The proposed method was validated for selectivity, precision, linearity, and accuracy. All validation parameters were within the acceptable range. Linearity studies for S Alogliptin was performed on (05-20μg/ml) and for Metformin (10-60μg/ml). The %RSD for accuracy found to be less than2%. Assay was found to be 99.17 to 101.65 respectively.

Keywords: RP-HPLC, Methanol, OPA, Metformin, Alogliptin.