A Novel RP-HPLC Method Development and Validation for the Determination of Pioglitazone and Glimepiride in Bulk and Pharmaceutical Formulations

A simple, precise, accurate, reproducible and economical stability- indicating reverse phase liquid chromatography method was developed and validated for the quantitative simultaneous estimation of Pioglitazone and Glimepiride in marketed formulations. Estimation of drugs in this combination was done with a C₁₈ column (Kromasil 100-5 column, 250mm x 4.6mm) using mobile phase of composition phosphate buffer pH 7: Acetonitrile in ratio 60:40 v/v. The flow rate was 0.8 ml/min and the effluents were monitored at 230 nm. The retention time of Pioglitazone and Glimepiride were 6.71 min and 8.38 min respectively. The method was found to be linear over a range of 10-50 μg/ml for Pioglitazone and 3-15 μg/ml for Glimepiride. The established method proved as reproducible one with a % RSD value of less than 2 and having the robustness and accuracy within the specified limits. Assay of marketed formulation was determined and find with 96% and 98% for Pioglitazone and Glimepiride respectively. The method was validated according to the guidelines of International Council for Harmonization (ICH) and was successfully employed in the estimation of commercial formulations. This liquid chromatographic method can be applied for the qualitative and quantitative determination of selected drugs by the modern chemist.