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

This paper describes the development and validation of an isocratic, revers ed-phase, high performance liquid chromatographic (HPLC) method for the ass ay of 200-mg troglitazone tablets. The chromatographic conditions of the me thod employ a YMC ODS-A, 120 Angstrom (4.6 x 150 mm, 5 mum) column, isocrat ic 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 mul in jection volume, and ultraviolet (UV) detection at 225 nm. The active was an alyzed at ambient column temperature, using peak area responses. (C) 2000 E lsevier Science B.V. All rights reserved.