DEVELOPMENT AND VALIDATION OF BIOANALYTICAL RP-HPLC METHOD FOR DETERMINATION OF CARVEDILOL AND DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF CARVEDILOL IN BULK DRUG AND FORMULATION

A new method is established for estimation of Carvedilol by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Carvedilol by using Agilent column (4.6×150mm) 5μ, flow rate was 1.0 ml/min, mobile phase ratio was di-potassium hydrogen phosphate: MeoH (25:75% v/v),detection wavelength was 270 nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The retention times were found to be 5.242 mins. The % purity of Carvedilol was found to be 98.56%. The system suitability parameters for Carvedilol such as theoretical plates and tailing factor were found to be 4343.2, 1.6. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Carvedilol was found in concentration range of 20μg-100μg and correlation coefficient (r2) was found to be 0.999, % recovery was found to be 98.96%, % RSD for repeatability was 0.3, % RSD for intermediate precision was 0.8. The precision study was precision, robustness and repeatabilty. LOD value was 0.7 and LOQ value was 0.13. Hence the suggested RP-HPLC method can be used for routine analysis of Carvedilol in API and Pharmaceutical dosage form.