Reversed-phase HPLC methods for purity test and assay of pioglitazone hydrochloride in tablets.
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.
Jedlicka
A
A
Department of Pharmaceutical Chemistry and Drug Control, Faculty of Pharmacy, Charles University, Hradec Králové, Czech Republic. Jedlicka@leciva.cz
Klimes
J
J
Grafnetterová
T
T
D002851:Chromatography, High Pressure Liquid; D007004:Hypoglycemic Agents / Q000032:analysis*; D013058:Mass Spectrometry; D000077205:Pioglitazone; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets; D045162:Thiazolidinediones / Q000032:analysis*
D007004:Hypoglycemic Agents; D013607:Tablets; D045162:Thiazolidinediones; D000077205:Pioglitazone