Development of New Validated RP-HPLC Method for Estimation of Anastrazole in Bulk and Tablet Dosage Forms

ABSTRACTA simple, Precised, Accurate method was developed for the estimation of Anastrozole by RP-HPLC technique. Chromatographic conditions used are stationary phase  Azilent  C18 (150mm x 4.6mm, 5mm) Mobile phase 0.01N Kh2Po4:Acetonitrile  in the ratio of 60:40 and flow rate was maintained at 1.0 ml/min, detection wave length was 215 nm, column temperature was set to 30oC and diluent was mobile phase Conditions were finalized as optimized method. The retention time was found to be 2.248 min. System suitability parameters were studied by injecting the standard six times and results were well under the acceptance criteria. Linearity study was carried out between 25% to150 % levels, R2 value was found to be as 0.999. Precision was found to be 0.5 for repeatability and 0.6 for intermediate precision. LOD and LOQ are 0.086µg/ml and 0.261µg/ml respectively. By using above method assay of marketed formulation was carried out 100.11% was present. Degradation studies of Anastrozole 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 Anastrozole. Keywords: HPLC Anastrozole, Method development, ICH Guidelines.