Simultaneous estimation of pioglitazone, glimepiride and glimepiride impurities in combination drug product by a validated stability- indicating rp-hplc method

• G NAVANEETHAN ^[1] ; K KARUNAKARAN ^[1] ; K. P ELANGO ^[2]
  1. [1] Anna University Sona College of Technology Department of Sciences
  2. [2] Deemed University Gandhigram Rural Institute Department of Chemistry
• Localización: Journal of the Chilean Chemical Society (Boletín de la Sociedad Chilena de Química), ISSN-e 0717-6309, ISSN 0366-1644, Vol. 56, Nº. 3, 2011, págs. 815-818
• Idioma: inglés
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• Resumen

  • 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.