DEVELOPMENT AND VALIDATION OF FIRST ORDER DERIVATIVE SPECTRO-PHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF TACROLIMUS AND BERBERINE HYDROCHLORIDEAbstract
A simple UV spectrophotometric method using the first order derivative technique was developed for the simultaneous estimation of tacrolimus and berberine hydrochloride in nanoparticles. The tacrolimus and berberine hydrochloride stock solutions were prepared methanol and scanned in UV- region for first-order derivative spectrum. The zero-crossing point for tacrolimus and berberine hydrochloride was 369 nm and 263 nm, respectively. Linearity was established over the concentration range of 0.5-2.5 μg/ml and 5-25 μg/ml for tacrolimus and berberine hydrochloride with correlation coefficient (r2) value 0.9933 and 0.9796respectively. The method was validated according to ICH guidelines for validation parameters like accuracy, precision, the limit of detection, and the limit of quantification. They found to be within limits. The method was successfully applied for the quantitative estimation of tacrolimus and berberine hydrochloride in nanoparticles.
S. Patel *, C. Aundhia, A. K. Sen, A. Zanwar and K. Pandya
Department of Pharmacy, Sumandeep Vidyapeeth, Vadodara, Gujarat, India.
31 March 2020
14 August 2020
25 August 2020
01 April 2021