Abstract:A reversed phase high performance liquid chromatographic method for the determination of process related impurities in pioglitazone hydrochloride was developed and validated. Highquality 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 stab… Show more
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