Analytical methods Development and Validation of Crizotinib by RP-HPLC Technique

Abstract

A simple, précised, accurate method was developed for the estimation of Crizotinib by RP-HPLC technique. Chromatographic conditions used are stationary phase BDS 250 × 4.6 mm, 5 μ. Mobile phase buffer: Acetonitrile in the ratio of 60:40 and flow rate was maintained at 1 ml/min, detection wave length was 267 nm, column temperature was set to 30°C and diluents was methanol: water. System suitability parameters were studied by injecting the standard five times and results were well (50:50), conditions were finalized as optimized method under acceptance criteria. Linearity study was carried out between 25% to 150% levels, r2 value was found to be as 0.999. Precision was found to be 1.26 for repeatability and 0.93 for intermediate precision. LOD and LOQ are 0.080 μg/ml. By using above method assay of marketed formulation was carried out 100.24% was present.