High-Performance Liquid Chromatographic Method Optimization for Ondansetron Assay in Extemporaneous Topical Gel and in Marketed Products

Quamrun, Masuda; Mamoon, Rashid; Nasheed, Shams; Mullins, Randy

Abstract

High-Performance Liquid Chromatographic Method Optimization for Ondansetron Assay in Extemporaneous Topical Gel and in Marketed Products

Author(s): Quamrun Masuda, Mamoon Rashid, Nasheed Shams, Mullins Randy

Issue: Nov/Dec 2014 - Volume 18, Number 6

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Page(s): 520-525

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Abstract

The compounding and evaluation of ondansetron hydrochloride dihydrate topical gel, 2.5% w/w, were conducted in this study. The gelling agent was Carbopol 940. Ethanol 70% in purified water was used to dissolve the drug and disperse the gelling agent. A gel was formed by adding drops of 0.1 N sodium hydroxide solution. To assay this gel, we developed a simple and reproducible stabilityindicating high-performance liquid chromatographic method. This method was validated for specificity, accuracy, and precision. The compounded gel was assayed in triplicate, and the average recovery was 98.3%. Ondansetron marketed products were analyzed for comparison with the compounded formulation. Assay, accuracy, and precision data of the compounded topical gel were comparable to the marketed products.

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