Abstract

A NEW STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN, REMOGLIFLOZIN AND VILDAGLIPTIN IN PHARMACEUTICAL DOSAGE FORM

Yarraboyana Rakesh*, Dr. Sridhar Siddiraju, Dr. Ch Parthiban and P. Ajay kumar

ABSTRACT

A simple, rapid and robust reverse phase HPLC method was developed and validated for the simultaneous estimation of Metformin, Vildagliptin and Remogliflozin in pharmaceutical dosage form with forced degradation studies. Chromatographic conditions used are stationary phase Agilent C8 (150mm*4.6mm 5µm), Mobile phase 0.1N KH2PO4 and Acetonitrile as mobile phase in the ratio of 50:50 and flow rate was maintained at 0.9ml/min, detection wave length at 240nm, Temperature was set to 30oC. The mean retention times of Metformin, Vildagliptin and Remogliflozin were found to be 2.576, 2.137 and 2.963 min respectively. System suitability parameters were studied by injecting the standard six times and results were well under the acceptance criteria. Linearity study was carried out between 25% to150 % levels, R2 value was found to be as 0.999. All other validation parameters like precision, accuracy, LOD, LOQ and robustness were found to be within the limits. % recovery was obtained as 99.97%, 100.15% and 100.79% for Metformin, Vildagliptin and Remogliflozin respectively. The proposed method was found to be suitable and accurate for simultaneous estimation of Metformin, Vildagliptin and Remogliflozin no in Pharmaceutical dosage form.

Keywords: Metformin, Vildagliptin and Remogliflozin, RP-HPLC.