Method development and validation for the HPLC potency assay of troglitazone tablets.

摘要

This paper describes the development and validation of an isocratic, reversed-phase, high performance liquid chromatographic (HPLC) method for the assay of 200-mg troglitazone tablets. The chromatographic conditions of the method employ a YMC ODS-A, 120 A (4.6 x 150 mm, 5 microm) column, isocratic elution with (50 mM aqueous NaH2PO4, pH 4.0):acetonitrile:methanol, (35:50:15, v/v/v) as the mobile phase at a flow rate of 1.0 ml/min, a 10 microl injection volume, and ulltraviolet (UV) detection at 225 nm. The active was analyzed at ambient column temperature, using peak area responses.