BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF CANDESARTAN BY DERIVATIVE SPECTROSCOPY (FIRST ORDER)

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 was to develop a simple, sensitive, accurate, precise and rapid derivative spectrophotometric bioanalytical 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 268.8 nm for first order derivative spectroscopy. The linearity was obtained in the range 2 – 10 µg/ml with a regression coefficient of R² = 1. The limit of detection is 0.99 µg/ml and limit of quantification was found to be 3.1 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. Thus, Bioanalytical method development by first order derivative spectroscopy method is simple, rapid and reproducible and further it can be used for the analysis.