RP-HPLC Method Development and Validation for Estimation of Doxorubicin and in Bulk and Pharmaceutical Dosage Form

Abstract

A simple, Precised, Accurate method was developed for the estimation of doxorubicin by RP-HPLC technique. Chromatographic conditions used are stationary phase Discovery C18 150mm x 4.6 mm, 5? ,Mobile phase 0.1% OPA: Acetonitrile in the ratio of 45:55 and flow rate was maintained at 0.9ml/min, detection wave length was 234 nm, 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 between 25% to150 % levels, R2 value was found to be as 0.999. Precision was found to be 0.6 for repeatability and 0.7 for intermediate precision. LOD and LOQ are 0.085?g/ml and 0.258?g/ml respectively. By using above method assay of marketed formulation was carried out 99.90% was present. Degradation studies of doxorubicin were done, in all conditions purity threshold was more than purity angle and within the acceptable range.