DEVELOPMENT AND VALIDATION OF A HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF PIOGLITAZONE AND GLIMEPIRIDE IN BULK AND TABLET DOSAGE FORM

Abstract

A simple high-performance liquid chromatographic (HPTLC) method has been developed and validated for simultaneous determination of pioglitazone and glimepiride in bulk and tablet dosage form. The method employed TLC aluminium plates precoated with silica gel 60 F 254 as the stationary phase. The mobile phase used was a mixture of Benzene: Ethyl acetate: Diethyl ether 6:3:1 v/v. The detection of spot was carried out at 254 nm. The calibration curve of pioglitazone was found to be linear between response was determined of 600 ng/ml to 3600 ng/ml with regression coeficent 0.9984 and calibration curve of glimepiride was found to be linear between 200-1200 ng/ml for glimepiride with regression coefficient of 0.9991. The limit of detection was 57.22 ng/ml and 16.67 ng/ml and the quantification limit was 190.73 ng/ml and 55.58 ng/ml for pioglitazone and glimepiride respectively.The proposed method can be successfully used to determine the drug content of marketed formulation. The accuracy of the proposed method was determined by recovery studies and found to be 97.84 to 99.07 %. The proposed method is applicable to routine analysis of Pioglitazone in bulk and pharmaceutical formulations. The proposed method was validated according to various ICH parameters like linearity, accuracy, precision, specificity, limits of detection, limits of quantification, range and solution stability.