Stability indicating method development and validation for the estimation of belinostat by rp-hplc method in bulk and pharmaceutical dosage form
Keywords:
HPLC Belinostat, Method development. ICH GuidelinesAbstract
A simple, Precise, Accurate method was developed for the estimation of Belinostat by RP-HPLC technique. Chromatographic conditions used are stationary phase Discovery c18 250 x 4.6 mm, 5 m. Mobile phase O- phosphoric acid buffer: Acetonitrile in the ratio of 50:50and flow rate was maintained at 1ml/min, detection wave length was 230nm, column temperature was set to 30oC and diluent was Acetonitrile: Water (50:50), Conditions were finalized as optimized method. System suitability parameters were studied by injecting the standard five 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 0.2 for repeatability and 0.4 for intermediate precision. LOD and LOQ are 0.42µg/ml and 1.28µg/ml respectively. By using above method assay of marketed formulation was carried out 100.83% was present.
Published
Issue
Section

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.