DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR QUANTIFICATION OF TACROLIMUS IN BULK AND A CAPSULE DOSAGE FORM BY UV SPECTROSCOPY METHOD

Quantitative and qualitative analysis of one or more analytes with stepwise instructions involves specific analytical technique. UV Spectroscopy is one of the analytical methods which involve the study of amount of light absorbed at each wavelength of UV and visible region. The present study is 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. The method development was done using phosphate buffer pH 7.4.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 7.4 in the concentration range of 10-100 µg/ml and the linear regression coefficient (R²) was found to be 0.999.The λ_max was found to be at 294 nm and the developed method was found to be precise within the interday and intraday studies and showed percentage Relative standard deviation of 1.759 and 1.566 % respectively. Thus a precise, simple and cost-effective UV-Vis method for the determination of tacrolimus was developed. The method developed was found to be precise, robust, simple and cost-effective method for the determination of tacrolimus in the bulk and in the pharmaceutical dosage form with regression coefficient (R²) of 0.999.

Key words:  Tacrolimus, regression coefficient, UV spectrophotometry, Method validation