RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF METFORMIN HYDROCHLORIDE, ROSIGLITAZONE AND SITAGLIPTIN – APPLICATION TO COMMERCIALLY AVAILABLE DRUG PRODUCTSAbstract
A simple, precise and stability-indicating HPLC method was developed and validated for the simultaneous determination of anti-diabetic drugs Metformin hydrochloride (MT), Rosiglitazone (RT) and Sitagliptin (ST). The separation was achieved on ACE 3 150 mm X 4.6mm, 3.5µm column using gradient method. The mobile phase at a flow rate of 1.5 mL min−1 consisted of 10 mM sodium hexane sulphonate monohydrate and 10 mM Potassium dihydrogen phosphate buffer with acetonitrile and methanol in Gradient ratio. The UV detection was carried out at 210 nm. The forced degradation for these drug substances were performed under Acid, Base, Oxidative, Photolytic and Thermal stress conditions. The method was successfully validated in accordance to ICH guidelines. Further, the validated method was applied for commercially available pharmaceutical dosage form.
Hitesh P. Inamdar*and Ashok A. Mhaske
Research Officer, Getz Pharma Research Pvt Ltd. Ambernath (East), Mumbai, Maharashtra, India
23 May, 2012
20 June, 2012
27 August, 2012
01 September, 2012