Abstract

METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF PIOGLITAZONE HYDROCHLORIDE BY RP-HPLC AND ITS APPLICATION IN BULK AND PHARMACEUTICAL DOSAGE FORM

Dr. Ch. Saibabu*, P. Narasimha Naidu, Dr. M. Bhaskar

Abstract

A simple, precise and stability-indicating HPLC method was developed and validated for the simultaneous determination of anti-diabetic drugs. The separation was achieved on ACE 3 150mm x 4.6mm, 3.5µm column with gradient flow. The mobile phase at a flow rate of 1.5 mL min−1 consisted of 10mM sodium hexane sulphonate monohydrate and 10mM Potassium dihydrogen phosphate buffer with acetonitrile and methanol in gradient ratio. The UV detection was carried out at 210 nm. The method was successfully validated in accordance to ICH guidelines. Further, the validated method was applied for commercially available pharmaceutical dosage form.

Keywords: Anti-diabetic drugs, Validation, HPLC, Analysis, ICH.