A simple, accurate and precise validated RP-HPLC method for determination of Sirolimus has been developed. Analysis was carried out on Shimadzu HPLC system with Kromasil C18 column (180 x 4.6 mm i.d, 5µm particle size) using Acetonitrile: 0.01 % v/v Ortho-phosphoric acid in gradient proportion (Analysis time 0 min, 50% acetonitrile; analysis time 15 min, 75% acetonitrile; analysis time 15.1 min, 50% acetonitrile; analysis time 20 min, 50% acetonitrile) as mobile phase with flow rate of 1.3 mLmin-1. The detection was carried out using UV detector set at 277 nm. For this method, Beer’s law is obeyed in the concentration range of 20.0 to 80.0 µg mL–1 of Sirolimus. The developed method has been successfully applied for the analysis of drug in bulk and pharmaceutical formulations. The mean percent recoveries were found to be 98.8 ± 0.5 for Brand formulation. The method was validated with respect to linearity, precision and accuracy as per the International Conference on Harmonisation (ICH) guidelines.
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