Abstract

DEVELOPMENT AND VALIDATION OF STABILITY – INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORM

Surla Durga, Sappa Pavani Naidu, Revu Baby Nalanda, Atla Srinivasa Rao*, Bolla Nagamani

ABSTRACT

The aim of the present study is to develop stability-indicating reverse phase-high performance liquid chromatography method for the simultaneous estimation of pioglitazone hydrochloride and metformin hydrochloride. The method uses a Agilent Variant C18 reverse phase column (150mm×4.6mm, 5μm) with mobile phase consisting of Methanol: 0.1 %v/v Ortho-phosphoric acid (45:55) under isocratic mode with an injection volume 20μL and both the analytes were monitored at 230 nm. Stress conditions were performed by subjecting the individual analytes to the hydrolysis (acidic, basic), oxidation and photolytic stress conditions. Considerable degradation of the both drugs was observed in alkaline hydrolysis and in oxidation stress conditions. The retention times of metformin hydrochloride and pioglitazone hydrochloride were 1.63 and 3.8 min, respectively and showed a good linearity in the concentration range of 5-50μg/ml for metformin hydrochloride and 5.02-50.19μg/ml for pioglitazone hydrochloride with a correlation coefficient of 0.999 for both drugs. None of the degradation products or excipients interfered with the retention time of the drugs. The validation parameters like specificity, system suitability, accuracy, precision, linearity, limit of detection, quantification, robustness and ruggedness were all within limits as per International Conference on Harmonization (ICH) guidelines. The proposed RP-HPLC-UV method is specific, accurate and precise and was successfully applied for the simultaneous estimation of pioglitazone hydrochloride and metformin hydrochloride in bulk and tablet dosage forms.

Keywords: Pioglitazone hydrochloride, Metformin hydrochloride, Simultaneous estimation, Stability indicating assay, Reverse phase liquid chromatography, Degradation products.