Vol. 4, Issue 4 (2019)
Method development and validation of forced degradation studies of pioglitazone hydrochloride by using UV Spectroscopy
Author(s): KV Ramanjaneyulu, SK Ayesha BI, B Jeevan Reddy, M Chandu, M Keerthi
Abstract: Pioglitazone hydrochloride is an oral anti diabetic agent used in the treatment of type 2 diabetes mellitus and also known as non-insulin dependent diabetes mellitus (NIDDM) or adult onset diabetes. A simple, an accurate and economic, precise and reproducible UV Spectroscopy method has been developed for the estimation of Pioglitazone hydrochloride tablet dosage form and validated by ICH guidelines. The standard (10 μg/ml) was scanned between 200-400 nm and maximum absorption was recorded at 270 nm. The assay results are found to be 99.7±0.352. The linearity range of 10-50 μg/ml proved that it obeyed Beer’s Law and the correlation coefficient (r2) was found to be 0.99986 at 270 nm with an intercept of 0.008and a slope of 0.011 with RSD 0.187 complied ICH. The pH degradation studies of tablet formulation were found to be less at pH 6-8. The force degradation studies of pioglitazone tablet formulation was done on Stress degradation by hydrolysis under alkaline condition by using 0.1N NaOH was found to be 13.07% for 60min, 17.95% for 90min. Stress degradation by hydrolysis under acidic condition by using 3N HCl and product degradation was found to be 19.75% for 60min and 21.79% for 90 min. Dry heat induced degradation was done by using 700c temperature was found to be 0.14% for 48 hrs. Oxidative degradation was done by using hydrogen peroxide and product degradation was found to be 12.65%for 15 min. Photolytic degradation was found to be 12.53% for 3hrs and 18.36% for 6hrs.