Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATON OF METFORMIN AND SITAGLIPTIN

H.Padmalatha* and M.Harish,

ABSTRACT

A New, precise, rapid, accurate RP-HPLC method was developed for the Simultaneous Estimation of Metformin and Sitagliptin in tablet dosage form. After optimization the good chromatographic separation was achieved by Isocratic mode with a mixture of Phosphate Buffer(PH 3.3) and Methanol in the ratio of 80:20 v/v as the mobile phase with Alltima C18 (150 x 4.6 mm, 5m) column as stationary phase at flow rate of 1.0 mL/min and detection wavelength of 210 nm. The retention times for Metformin and Sitgliptin found to be 2.35 min and 3.04 min respectively. The linearity of this method was found in the concentration range of 50 μg/mL to 300 μg/mL for Metformin and 5 μg/mL to 30 μg/mL Sitgliptin. The correlation coefficient R2 value is found to be 0.9998 for Metformin and 0.9993 for Sitgliptin. The LOD and LOQ for Metformin were found to be 0.38 μg/mL and 1.14 μg/mL repectively and 0.19μg/mL and 0.58μg/mL for Sitagliptin. The Proposed method was found to be Linear, precise and accurate for the quantitative estimation Metformin and Sitagliptin in Bulk and Tablet dosage form and can be used for commercial purposes.

Keywords: Metformin, Sitagliptin, RP-HPLC ethod,Simultaneous estimations.