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International Journal of
Research in Pharmacy and Pharmaceutical Sciences
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VOL. 4, ISSUE 4 (2019)
Method development and validation of forced degradation studies of pioglitazone hydrochloride by using UV Spectroscopy
Authors
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.
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Pages:01-06
How to cite this article:
KV Ramanjaneyulu, SK Ayesha BI, B Jeevan Reddy, M Chandu, M Keerthi "Method development and validation of forced degradation studies of pioglitazone hydrochloride by using UV Spectroscopy". International Journal of Research in Pharmacy and Pharmaceutical Sciences, Vol 4, Issue 4, 2019, Pages 01-06
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