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  Home::CANDESARTAN CILEXETIL ANALYTICAL METHOD DEVELOPMENT AND VALIDATION STUDIES BY REVERSE PHASE HPLC TE
  CANDESARTAN CILEXETIL ANALYTICAL METHOD DEVELOPMENT AND VALIDATION STUDIES BY REVERSE PHASE HPLC TE
   

Analytical method development and validation of process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. It helps to improve the reliability, consistency and accuracy of analytical data. Present investigation involves development and validation of chromatographic method of Candesartan Cilexetil as per ICH guidelines by RP-HPLC. Development of common HPLC method for Candesartan cilexetil. Liquid chromatographic method using the following chromatographic conditions: A stainless steel column- Zorbax SB- CN, 150x 4.6 mm, 5m, a mixture of 40 volumes of 10Mm of sodiumdihydrogen ortho phosphate adjusted to a pH 2.5 0.05 with orthophosphoric acid and 60 volumes acetonitrile (filter and degas), as the mobile phase, flow rate of 1.0 ml per minute, a detection wavelength of 210 nm, column oven temperature 30C and injection volume 20l. Developed method was validated by various parameters viz., Precision, Accuracy, Linearity, Robustness and Ruggedness. In this study, the HPLC method of candesartan cilexetil has been developed and validated. The validation is performed according to the current requirements as laid down in the ICH guidelines. The results were found to be within the acceptance limit corresponding to %RSD and degradation was to be less than 20%. Developed HPLC method was accurate and precise hence it could be conveniently used for the estimation of Candesartan Cilexetil in bulk and also all the analytical parameters were found to be within the limits. Therefore it could conclude that the method is suitable for its intended use.

Date: 13, Dec 2012 Posted By: admin
   
 
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