UV Spectrophotometric Method for the Determination of Sirolimus in Bulk and its Dosage Form Mastanamma S K.1,*, Reehana S K.2, Prudhvi L.3, Kiran Ravi3 1Department of Pharmaceutical Analysis, University College of Pharmaceutical Science, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur-522510, Andhra Pradesh (India) 2Scholar, Department of Pharmaceutical Analysis, University College of Pharmaceutical Science, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur-522510, Andhra Pradesh (India) 3B. Pharm Student, Department of Pharmaceutical Analysis, University College of Pharmaceutical Science, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur-522510, Andhra Pradesh (India) *Corresponding Author E-mail: masthanamma.sk@gmail.com
Online published on 8 August, 2019. 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 λmax 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. Top Keywords Sirolimus, Dimethyl Sulfoxide, UV, Validation. Top |