Reverse phase-HPLC method for the analysis of Naltrexone hydrochloride in bulk drug and its pharmaceutical formulations

By Prakash S. Sarsambi, Abdul Faheem, Abhay Sonawane, D. Gowrisankar

 

Abstract

A simple, precise, rapid and reproducible reversed phase high performance liquid chromatographic method has been developed for the quantitative estimation of Naltrexone Hydrochloride (NAL) in bulk drug and its formulation dosage forms using column oyster (250 x 4.6mm, 5µm). Mobile phase consist of combination of ammonium acetate buffer (pH 5.8) and acetonitrile in the ratio 60: 40 v/v respectively and was pumped at 1.0 mL/min and the injection volume was 10 µL. The detection was carried out at 220nm and calibration curve was linear in the range of 12-36 µg/mL. The method was validated statistically for its linearity, precision, accuracy. The intra- and inter-day variation was found to be less than 1% showing high precision of the assay method. Due to its simplicity, rapidness, high precision and accuracy, the proposed HPLC method may be used for determining NAL in bulk drug sample and its pharmaceutical formulations.

 

Key Words : NAL, RP-HPLC and Naltrexone

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