Abstract

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

 Yaraveda Lathareddy*, Naidu Srinivasa Rao

 Department of Pharmaceutical Analysis & Quality Assurance, JNTU Kakinada University, Vikas College of pharmacy, Andhra Pradesh, India.

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 & Sitagliptin (JANUMET) in pharmaceutical dosage forms. Chromatographic separation of MET & SITA was achieved on AGILENT CN , 250mm x 4.6mm, 5μm and the mobile phase containing OPA buffer & Acetonitrile in the ratio of 80:20 v/v. The flow rate was 1.0 ml/min, detection was carried out by absorption at 205nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for MET & SITA were NLT 3000 and should not more than 2 respectively. JANUMET was 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 25-750μg/ml and 3-75 μg/ml for MET & SITA respectively. The correlation coefficient was 0.999. Relative standard deviations of peak areas of all measurements were always less than 2.0%. The proposed method was validated according to ICH guidelines. And it was found to be suitable and accurate method for quantitative analysis of JANUMET and study of its stability.

Keywords: High performance liquid chromatography, Metformin, Sitagliptin & JANUMET