STABILITY INDICATING ISOCRATIC RP-HPLC AND SECOND DERIVATIVE UV SPECTROSCOPIC METHODS FOR SIMULTANEOUS DETERMINATION OF REMOGLIFLOZIN ETABONATE AND VILDAGLIPTIN HYDROCHLORIDE

Abstract

Remogliflozin and Vildagliptin are the latest drug combination in order to treat type 2 diabetes. The present work describes a comparative study of 2nd-ordered derivative UV and isocratic stability indicating RP-HPLC methods for simultaneous determination of Remogliflozin and Vildagliptin in the drug and its formulation. The HPLC method was established with a C18 column and the mobile phase with Buffer (pH-6.50): Acetonitrile: Methanol ratio of 55: 44: 1, at 1.2 ml/min flow and wavelength of 210 nm. The UV spectrophotometric method works on spectrophotometry with 2nd order derivative spectra (2D) using a zero-line cross method. The absorbance determination was performed at 246.0 nm for REM and at 219. 6 nm for VIL. The methods were validated for Linearity, Precision, Recovery, Robustness, and Forced degradation as per ICH-Q2 (R1). The linear range was established in the range of 4-80 ppm for REM and 2-40 ppm for VIL for the UV method and 2-200 ppm for REM and 1-100 ppm for VIL for the HPLC method with regression coefficient≥ 0.990. The accuracy was 99.37% & 99.62% for UV and 100.98 & 100.65 for the HPLC method for REM and VIL respectively. The proposed methods have been effectively used for the quantification of REM and VIL in API mixture and formulation dosage forms. Both methods are economical, fast, simple, and accurate which can be easily adopted for laboratory use.