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Abstract

Method Validation and Estimation of Anagrelide Hydrochloride in Pharmaceutical Dosage by RP-HPLC Method

A simple, fast and reproducible reverse phase liquid chromatography (RP-HPLC) method was developed for the determination of Anagrelide Hydrochloride in bulk drug and pharmaceutical dosage form. The method was developed using Inertsil ODS-3V C18 (150 × 4.6 mm, 5 μm) column, mobile phase 0.1% triethylamine in Milli-Q-water (pH 3.0 adjusted with orthophosphoric acid) and acetonitrile in the ratio of 70:30% v/v with isocratic elution at a flow rate of 1 mL/min. System Suitability test were performed for the assurance of quality performance of method. The drug was subjected to accelerated degradation for photolytic, hydrolytic, thermal, oxidative conditions. The retention time of Anagrelide Hydrochloride was found to be 6.985 min. The method was validated for accuracy, precision, specificity, linearity, limit of detection, limit of quantitation 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 2.99 μg/ml and limit of quantitation was found to be 9.96 μg/ml. 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.


Author(s):

Nataraj KS, Prasanna Lakshmi B and Sravanthi I



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