M. M. Baker, D. S. El-Kafrawy, M. Abdel-Khalek
Sep 11, 2019
Citations
0
Influential Citations
8
Citations
Journal
Journal of separation science
Abstract
This research deals with development of a stability-indicating HPLC method for simultaneous determination of amprolium hydrochloride and ethopabate. To the best of our knowledge, no comprehensive stability-indicating method has been reported for analysis of this mixture. Separation was achieved using Kromasil cyano column with gradient elution of the mobile phase composed of sodium hexane sulfonate solution and methanol. Quantification was based on measuring peak areas at 266 nm. Amprolium and ethopabate peaks eluted at retention times 10.42 and 18.53 min, respectively. The proposed procedure was validated with respect to system suitability, linearity, ranges, precision, accuracy, specificity, robustness, detection and quantification limits. Linearity ranges for amprolium and ethopabate were 1.5-240 and 1-160 μg/mL respectively. Analytes were subjected to stress conditions of hydrolysis, oxidation and thermal degradation. The proposed method enabled resolution of drugs from their forced-degradation products and amprolium related substance (2-picoline). Moreover, specificity was verified by resolution of the analytes from about 22 drugs used in antimicrobial veterinary products. The validated method was successfully applied to assay of the combined veterinary powder dosage form, additionally it was implemented in the accelerated stability study of the dosage form when stored for 6 months at 40°C and 75% relative humidity. This article is protected by copyright. All rights reserved.