Development and Validation of UV Spectrophotometric Method for Determination of Tacrolimus in Bulk and Capsule Dosage Form

Abstract

Background The present study aimed to develop and validate a rapid robust effective specific and accurate UV-Vis method for the determination of Tacrolimus in pharmaceutical dosage forms according to International Conference on Harmonization ICH Q2 R1 guidelines.Methodology The method development was done using phosphate buffer of pH 6.8. The method validation parameters like linearity precision accuracy robustness and ruggedness were assessed for the developed method. Pure drug solutions were prepared using Phosphate buffer pH 6.8 the aliquots of concentration range 1-10 microgmL and therefore the linear regression coefficient R2 was 0.999.Results The optimum lambdamax was at 295 nm. The developed method was precise within the interday and intraday studies and showed percentage RSD of 1.731 and 1.243 respectively. Thus a precise simple and cost-effective UV-Vis method for the determination of Tacrolimus was developed.Conclusion The method developed was found to be precise robust simple and cost-effective for the determination of Tacrolimus in bulk and in pharmaceutical dosage forms with regression coefficient R2 of 0.999.