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oai:ojs.www.eurjchem.com:article/1058 2014-09-30T03:41:50Z eurjchem:ART driver

Development and validation of a new RP-HPLC method for the determination of process related impurities in pioglitazone hydrochloride Prava, Venkata Raj Kumar Seru, Ganapaty RP-HPLC Thiazolidinedione Method development Forced degradation study Process related impurities Pioglitazone hydrochloride A reversed phase high performance liquid chromatographic method for the determination of process related impurities in pioglitazone hydrochloride was developed and validated. High-quality separation was achieved on a Luna C18 column (150 mm × 4.6 mm, 3 µm) using gradient elution at a flow rate of 1 mL/min and a column temperature of 45 °C. UV detection was performed at 254 nm. The validation was performed according to the International Conference on Harmonization (ICH) guidelines. In addition, the solution stability and method robustness were examined. The method gives satisfactory separation of impurities of pioglitazone hydrochloride and so it is suitable for quantification of the process related impurities as well as for the assay of the active compound. Atlanta Publishing House LLC 2014-09-30 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion application/pdf https://www.eurjchem.com/index.php/eurjchem/article/view/1058 10.5155/eurjchem.5.3.469-474.1058 European Journal of Chemistry; Vol. 5 No. 3 (2014): September 2014; 469-474 2153-2257 2153-2249 eng https://www.eurjchem.com/index.php/eurjchem/article/view/1058/pdf_1058