Development of RP-HPLC method and validation for the quantitative estimation of everolimus in bulk form and marketed tablet dosage form

Abstract

A selective, accurate and precise RP-HPLC method was developed and validated for the estimation of Everolimus in bulk and marketed pharmaceutical dosage forms. The Everolimus was resolved on a Symmetry ODS C18 (4.6mm × 250mm, 5µm) using Methanol: Phosphate Buffer used in the ratio of 35:65% v/v as the mobile phase. The detection wavelength was 235 nm. The retention time obtained for Everolimus were 3.006 min. The linearity ranges were 6-14 with Regression coefficients of 0.9996. The % R.S.D. of precision studies was found to be 0.175. The accuracy of the proposed method was determined by recovery studies and the mean recovery was 100.72%. The limit of detection and the limit of quantitation were found to be 1.2μg/ml and 3.6μg/ml, respectively. Different analytical performance parameters such as precision, accuracy, limit of detection, limit of quantification and robustness were determined according to International Conference on Harmonization (ICH) guidelines. Thus the novel proposed method for Everolimus was found to be feasible for the estimation of Everolimus in bulk as well as the pharmaceutical dosage form.