Abstract

STABILITY-INDICATING RP-HPLC METHOD AND ITS VALIDATION FOR ANALYSIS OF METFORMIN HYDROCHLORIDE & SITAGLIPTIN PHOSPHATE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Naidu Srinivasa Rao*, Dr.K. Venkataramana, and P.Anitha

Abstract

A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Metformin hydrochloride & Sitagliptin Phosphate in pharmaceutical dosage forms. Chromatographic separation of MET & SITA was achieved on Zodiac C18 , 150mm x 4.6mm, 5μm and the mobile phase containing TEA buffer & Methanol in the ratio of 80:20 v/v. The flow rate was 1.0 ml/min, detection was carried out by absorption at 224nm using a photodiode array detector at ambient temperature. The RT of Metformin hydrochloride and Sitagliptin Phosphate is found to be 3.6 and 5.3 min. The drugs were exposed to thermal, photolytic, hydrolytic, acid, alkali, and oxidative stress and the stressed samples were analyzed by use of the proposed method & chromatograms from the stressed samples, obtained by use of the photodiode-array detector. The linearity of the method was excellent over the range 80- 730μg/ml and 8-70 μg/ml for MET & SITA respectively. The correlation coefficient was 0.999. The proposed method was validated according to ICH guidelines. And it was found to be suitable and accurate method for quantitative analysis of Dosage form and study of its stability.

Keywords: High performance liquid chromatography, forced degradation, Metformin hydrochloride, Sitagliptin Phosphate.