Development of HPLC Method for Simultaneous Estimation for Pioglitazone, Glimepiride, Glimepiride Impurities from a Combination Drug Product

The goal of this paper is to develop a single HPLC method for estimating pioglitazone, glimepiride, glimepiride impurity B, and impurity C from a combination drug product simultaneously. By dissolving sufficient amounts of glimepiride impurity B, impurity C, and glimepiride (1000 |ig/mL) in methanol, stock solutions of glimepiride impurity B, impurity C, and glimepiride (1000 |ig/mL) were prepared. By dissolving the required volume of pioglitazone and glimepiride standard in diluent, a standard solution containing 750 |ig/mL pioglitazone and 100 |ig/mL glimepiride was prepared. Many of the system validation criteria were found to be sufficient, and the method was thoroughly validated. The developed procedure, which can be used for routine examination to determine the compound, may support both quality control departments and commercial sample purity tests.