DEVELOPMENT AND VALIDATION OF RP - HPLC METHOD FOR THE ESTIMATION OF SIROLIMUS IN FORMULATION AND SERUM

A simple, selective, linear, precise and accurate RP-HPLC method was developed and validated for rapid assay of Sirolimus in tablet dosage form. Isocratic elution at a flow rate of 1.0ml/min was employed on a symmetry C18 (250x4.6mm, 5μm in particle size) column at ambient temperature. The mobile phase consisted of acetonitrile : methanol 20:80 (V/V). The UV detection wavelength was 272nm and 20μl sample was injected. The retention time for Sirolimus was 2.740 min. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The method was validated as per the ICH guidelines. The method developed can be applied for routine analysis of Sirolimus in tablet dosage form and in serum.