METHOD DEVELOPMENT AND VALIDATION OF EVEROLIMUS BY USING RP-HPLC
Devavath Renuka*, Nalla Kumar P. and Bhagavan Raju M.
Abstract
Objective: To develop and validate the RP-HPLC method for
estimation of Everolimus in bulk and pharmaceutical formulation.
Materials and methods: Estimation of Everolimus were carried out
by RP-HPLC using Mobile phase Buffer: Acetonitrile (40:60) and
column std ODS (250×4.6mm, 5μ) as a stationary phase and peak was
observed at 268nm which was selected as a wavelength for estimation.
Results: Method was developed and this method was validated as per
ICH guidelines for specificity, linearity, precision, accuracy,
robustness studies. Conclusion: All the validated parameters were
within the limits. The method was found to be suitable for the
estimation of Everolimus in bulk and pharmaceutical formulation.
Keywords: HPLC Everolimus, Method development. ICH Guidelines.
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