Analytical Method Development And Validated Stability For The Estimation Of Vismodegib In Bulk Dosage Forms By Rp-Hplc Method

Abstract

A simple, Précised, Accurate method was developed for the estimation of Vismodegib by RP-HPLC technique. Chromatographic conditions used are stationary phase ODS C18 (250mm*4.6mm3.6), Mobile phase0.01N KH2PO4: Acenotrile in the ratio of 65:35 and flow rate was maintained at 0.8ml/min, detection wave length was 264nm, column temperature was set to 30oC and diluent was mobile phase Conditions were finalized as optimized method. System suitability parameters were studied by injecting the standard six times and results were well under the acceptance criteria. Linearity study was carried out between25% to150 % levels, R2 value was found to be as 0.999. Precision was found to be 0.9 for repeatability and 0.8 for intermediate precision.LOD and LOQ are 0.33μg/ml and 0.99μg/ml respectively. By using above method assay of marketed formulation was carried out 99.86% was present. Degradation studies of Vismodegib were done, in all conditions purity threshold was more than purity angle and within the acceptable range. Full length method was not performed; if it is done this method can be used for routine analysis of Vismodegib.