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Separation and quantification of impurities of pioglitazone hydrochloride fromactive harmaceutical ingredient (API) using RPLC

Harlikar Jayvant Narayan, Amlani Arun Mahendra

High performance reverse phase liquid chromatography (HPLC) method was developed for quantification of impurities of pioglitazone hydrochloride from active pharmaceutical ingredient (API). Pioglitazone hydrochloride and its impurities were separated using reverse phase gradient HPLC method. The experimental procedure involved variable wavelength detector (at 230nm), the mobile phases consisting of mobile phase A of phosphate buffer andmobile phase Bof acetonitrile andmethanolmixture (65:35) were used. The flow rate of the mobile phase was adjusted to 1.0mL per minute on an Inertsil ODS 3V, C-18 (250mm  4.6mm, 5 size) column.A calibration curve showed good linearity within the LOQ to 0.4% of the test range (ie 0.2 ppmto 4 ppm). The recoveries ranged from93%to 105%. The %RSD for repeatabilitywas 2.5. The HPLCmethod is capable of detecting all process related impurities, whichmay be present in theAPI. Themethod was validated and from the results obtained it can be concluded that the method is suitable for the intended purpose of separation and quantification.