Abstract

HIGH PERFORMANCE LIQUID CHROMATOGRAPHY FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN HCL AND SITAGLIPTIN IN PHARMACEUTICAL DOSAGE FORMS

K. Vamsee Krishna Reddy* and R. Madhusudhan Raju

ABSTRACT

A simple, rapid, precise and accurate reverse-phase HPLC method was developed and validated for the simultaneous determination of Metformin HCL and Sitagliptin in commercial tablets. The method has shown adequate separation for Metformin HCL and Sitagliptin. Separation was achieved on Kromasil C8 (250 mm × 4.6mm; 5 µm) column using isocratic method with 0.1NaH2PO4:Methanol(60:40) system at room temperature and the detection was carried out at 235nm using photodiode array (PDA) detector. The linearity of the proposed method was investigated in the range of 50-150μg/ml (r2=0.9998), 5-15μg/ml (r2=0.999) for Metformin HCL and Sitagliptin Respectively. The limit of detection (LOD) was 0.341and 0.0495 for Metformin HCL and Sitagliptin respectively. The limit of quantification (LOQ) was 1.136 and 0.1650 for Metformin HCL and Sitagliptin respectively. The relative standard deviation (RSD) of six replicates is less than 2%. This HPLC method is applied successfully to the simultaneous quantitative analysis of Metformin HCL and Sitagliptin in commercial tablets.

Keywords: RP-HPLC, Metformin HCL ,Sitagliptin,Simultaneous Estimation.