Method development and validation for the HPLC potency assay of troglitazone tablets.
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.
Lambropoulos
J
J
Analytical Method Development and Validation, AAI, Inc., Chapel Hill, NC 27514, USA.
Bergholdt
A B
AB
D002839:Chromans / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D007004:Hypoglycemic Agents / Q000032:analysis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets / Q000737:chemistry*; D013844:Thiazoles / Q000032:analysis*; D045162:Thiazolidinediones; D000077288:Troglitazone
D002839:Chromans; D007004:Hypoglycemic Agents; D013607:Tablets; D013844:Thiazoles; D045162:Thiazolidinediones; D000077288:Troglitazone