Abstract

Impurity profile study of pioglitazone and glimepiride combination drug product by liquid chromatography

Author(s): Shraddha Pawar, Rajendra Jadhav, Yatish Bansal, Gangadhar Meshram

A reverse phase high- performance liquid chromatographic (RP-HPLC) method in gradient mode has been developed and evaluated for its ability to simultaneously establish the level of known impurities as well as the unknown impurities in pioglitazone and glimepiride tablets. The best separationwas achieved on Eclipse XDB-C8, 5m, 4.6  150mmcolumn.Use of 0.1N sodium dihydrogen phosphate dihydrate buffer pH 3.0, acetonitrile and methanol, asmobile phase at flowrate of 1.2 mLmin-1 enabled acceptable resolution of pioglitazone and glimepiride frompossible impurities.UV detectionwas performed at 230nm. The developedmethod was validated in termof selectivity, linearity, accuracy using spiked levels of impurities, precision (repeatability and reproducibility), limit of detection, limit of quantification and ruggedness. Overall, the proposed method was found to be highly sensitive, suitable and accurate for quantitative determination of known and unknown impurities in dosage form without any interference fromthe excipients.