DEVELOPMENT AND VALIDATION OF HPLC ANALYTICAL METHODS USED FOR DETERMINATION OF ASSAY, CONTENT UNIFORMITY AND DISSOLUTION OF IMMEDIATE RELEASE CANDESARTAN CILEXETIL 32 MG TABLETS


YÜCE M., ÇAPAN Y.

ACTA POLONIAE PHARMACEUTICA, vol.74, no.2, pp.357-367, 2017 (Journal Indexed in SCI) identifier identifier

  • Publication Type: Article / Article
  • Volume: 74 Issue: 2
  • Publication Date: 2017
  • Title of Journal : ACTA POLONIAE PHARMACEUTICA
  • Page Numbers: pp.357-367

Abstract

New analytical methods have been developed and validated on high performance liquid chromatography (HPLC) to assess the assay, content uniformity and dissolution of immediate release candesartan cilexetil 32 mg tablets. Method development studies were performed on cyano column. Mobile phase of assay and content uniformity test consisted of mixture of 0.05 M phosphate buffer, pH 4.5 and methanol (40 : 60, v/v) adjusted to pH 4.0 with trifluoroacetic acid, whereas mobile phase of dissolution test consisted of mixture of I mM phosphate buffer and acetonitrile (50 : 50, v/v) adjusted to pH 2.0 with tritluoroacetic acid. Mobile phases were pumped at flow rate of 1.0 mL/min, ultraviolet-visible (UV) detector was operated at 254 nm. injection volume was set at 20 mu L. column temperature was held at 25 degrees C. Dissolution medium was 0.05 M phosphate buffer, pH 6.5 including 0.70% (w/v) polysorbate 20. Validation studies met acceptance criteria of system suitability, specificity. linearity and range, accuracy, precision. detection limit (LOD). quantitation limit (LOQ) and robustness parameters.