Development and Validation of RP-HPLC Method for Simultaneous Estimation of Pioglitazone HCl and Glimepiride in Tablets

Author(s)

Pawar, J., Sonawane, S., Chhajed, S., Kshirsagar, S., Wagh, M.

Author's Affiliation

Abstract

The aim of this paper was to develop a simple and validated RP- HPLC method for simultaneous estimation of Pioglitazone HCl (PGZ) and Glimepiride (GLM) in tablet dosage form. Chromatographic separation was achieved on a Kinetics C₁₈ column (250 ´ 4.6 mm, 5m). The mobile phase comprised of Acetonitrile: 25 mM ammonium acetate buffer (pH 4.6) 60:40%v/v. Isocratic elution mode was used at flow rate of 1 mL/min and all eluents were detected at 230 nm. The validation parameters studied were linearity, accuracy, precision, specificity and robustness. Calibration curves at seven levels for PGZ and GLM were linear in the range of 5-35 mg/mL and 2-14 mg/mL, respectively. Accuracy for both PGZ and GLM were studied in the range of 80-120 % QC standard levels. The method was found to be precise with respect to repeatability and intermediate precision at all QC standard levels. There was no interference from excipient in the analysis of PGZ and GLM. Hence, the proposed method can be used for analysis of routine quality control samples of PGZ and GLM tablets.

Keywords

Pioglitazone HCl, Glimepiride, RP-HPLC, Analytical Method Validation

Cite This Article

Pawar, J., Sonawane, S., Chhajed, S., Kshirsagar, S., Wagh, M. (2016). Development and Validation of RP-HPLC Method for Simultaneous Estimation of Pioglitazone HCl and Glimepiride in Tablets, International Journal for Pharmaceutical Research Scholars (IJPRS), 5(2), 167-172.