ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF CANDESARTAN CILEXETIL IN BULK AND PHARMACEUTICAL DOSAGE FORMS BY THIRD ORDER DERIVATIVE SPECTROSCOPIC TECHNIQUE

摘要

Candesartan cilexetil, a prodrug is a racemic mixture containing one chiral center at the cyclohexyloxy-carbonyloxy- ethyl ester group. It is soluble in dimethyl formamide, acetone, methanol, 0.1 N sodium hydroxide solution and insoluble in water. Objective of the present study is to develop a simple, sensitive, accurate, precise and rapid derivative spectrophotometric method for the estimation of candesartan in pure form. For the estimation of candesartan, solvent system employed was absolute methanol and wavelength of detection (λ_det) was 294.3 nm for third order derivative spectroscopy. The linearity was obtained in the range 180 – 280 μg/ml. The regression equation was found to be y = 0.0001x + 0.003 & regression coefficient, R2 was found to be 0.999. The limit of detection is 6.7μg/ml and limit of quantification was fund to be 20.4 μg/ml. Obtained results showed that there is minimum intraday and inter day variation. The developed method was validated and recovery studies were also carried out. Sample recovery using the above method was in good agreement with their respective labeled claims, thus suggesting the validity of the method and non-interference of formulation excipients in the estimation. Third order derivative spectroscopy method is simple, rapid and reproducible and further it can be used for the analysis.