Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF ANAGRELIDE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORMS.

J.Sony*, C.Balashekaran, M.prasadarao.

ABSTRACT

A simple, fast and reproducible reverse phase liquid chromatography (RP-HPLC) method was developed for the estimation of anagrelide hydrochloride in bulk drugs and formulations. The method was developed using Hypercil ODS- C18 (150 × 4.6mm, 5μ) column, mobile phase 0.1% triethylamine in Milli-Q-water (pH 3.0 adjusted with orthophosphoric acid) and acetonitrile in the ratio of 60:40%v/v with isocratic elution at a flow rate of 1.5ml/min. System Suitability test were performed for the assurance of quality performance of method. The retention time of anagrelide hydrochloride was found to be 6.985min. The method was validated for accuracy, precision, reproducibility, specificity, limit of detection, limit of quantification and robustness as per ICH guidelines. All the parameters were within limits. The mean recovery was 99.9%. Limit of Detection was found to be 0.053μg/ml and Limit of Quantification was found to be 0.16μg/ml respectively. The proposed method gave good resolution of Anagrelide Hydrochloride and its degradation products. The developed method can be used for the routine quality control analysis in labs.

Keywords: Anagrelide Hydrochloride, RP-HPLC,Method development, validation, Force Degradation Study, ICH guidlines.