Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN HCL AND EMPAGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Dandu Girija* and Basu Venkateswara Reddy

ABSTRACT

The present study describes the development and validation of new stability indicating RP-HPLC method for simultaneous estimation of Metformin Hcl and Empagliflozin in bulk and pharmaceutical dosage form. The chromatographic separation was done by using reverse phase Inertsil-ODS column- 3V (250x4.6mm; 5μm) . The mobile phase used was mixture of Ortho Phosphoric Acid (OPA) buffer (pH 3.2) : Methanol (70:30) at flow rate of 1ml/ min and detection was carried out using PDA detector at 254nm. And these were eluted at retention times of 1.970 and 2.979 min respectively.The developed method showed a good linearity in the range of 250-750μg/ml for Metformin Hcl and 2.5-7.5μg/ml for Empagliflozin with regression co-efficient of 0.999 and 0.999 for both the drugs. The proposed method was accurate, precise, robust, stable and specific. The developed method was validated in accordance with ICH guidelines.

Keywords: Metformin HCl, Empagliflozin, RP-HPLC, methanol, Inertsil-ODS column.