Reversed-phase HPLC methods for purity test and assay of pioglitazone hydrochloride in tablets
A Jedlicka1, J Klimes, T Grafnetterová
1Department of Pharmaceutical Chemistry and Drug Control, Faculty of Pharmacy, Charles University, Hradec Králové, Czech Republic. Jedlicka@leciva.cz
Abstract:
A reversed-phase gradient HPLC method was developed for the evaluation of pioglitazone hydrochloride (PG-HCl) in tablets. Limit of detection for PG-HCl was found to be 42 ng/ml. Analyses were performed on a C18 column (Symmetry C18, 5 microm, 250 x 4.6 mm), mobile phase was a mixture of ammonium formate buffer adjusted with formic acid to pH 4.1 and acetonitrile. Shortened purity method was used as the assay method. Methods were validated.
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