UV Spectrophotometric Method for the Determination of Sirolimus in Bulk and its Dosage Form

Abstract

Objective: The main objective was to develop and validate the UV-Spectrophotometric method for the estimation of Sirolimus in bulk and pharmaceutical formulations as per ICH guidelines. Materials and methods: A simple, rapid, accurate, and economical UV-spectrophotometric method has been developed for the estimation of Sirolimus from bulk and pharmaceutical formulation. Results: The ?max of Sirolimus in Dimethyl Sulfoxide was found to be 274 nm. The drug follows linearity in the concentration range 3–21 µg/ml with a correlation coefficient value of 0.9956. The proposed method was applied to pharmaceutical formulation and % amount of drug estimated was 101.35%. and was found to be in good agreement with the label claim. The accuracy of the method was checked by recovery experiment performed at three different levels, i.e., 75%, 100%, and 125%. The % recovery was found to be in the range of 99.30– 101.03%. The low values of % RSD are indicative of the accuracy and reproducibility of the method. The precision of the method was studied as an intraday; interday variations, and repeatability. The % RSD value < 2 indicates that the method is precise. Conclusion: The above method was a rapid tool for routine analysis of sirolimus in the bulk and in the pharmaceutical dosage form.