Abstract

NAVANEETHAN, G; KARUNAKARAN, K  and  ELANGO, K. P. SIMULTANEOUS ESTIMATION OF PIOGLITAZONE, GLIMEPIRIDE AND GLIMEPIRIDE IMPURITIES IN COMBINATION DRUG PRODUCT BY A VALIDATED STABILITY- INDICATING RP-HPLC METHOD. J. Chil. Chem. Soc. [online]. 2011, vol.56, n.3, pp. 815-818. ISSN 0717-9707.  doi: 10.4067/S0717-97072011000300021.

A new, single, stability indicating RP-HPLC method has been developed and validated for the simultaneous estimation of pioglitazone, glimepiride and glimepiride impurities i.e., related compound B and related compound C from combination drug product containing pioglitazone, glimepiride and metformin HCl. The chromatographic separation was achieved on a cyano stationary phase (250 x 4.6mm, 5.0 microns particles) with simple mobile phase combination delivered in gradient mode at a flow rate of 0.8mL min¹ at 230nm. In the developed method, the critical close eluting compound of glimepiride related compound B and related compound C was found more than 6.5 resolutions. This method is capable to detect glimepiride related compound B and related compound C at a level below 0.005% with respect to glimepiride sample concentration of 0.1mg mL^-1 for a 25 µL injection volume. The proposed method was validated according to the ICH guidelines and proved suitable for routine and stability analysis of these drugs in pharmaceutical preparations.

Keywords : stability indicating; peak purity; impurities; validation.