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Journal of Analytical Methods in Chemistry
Volume 2017, Article ID 1529280, 7 pages
https://doi.org/10.1155/2017/1529280
Research Article

Development and Validation of a Stability-Indicating HPLC Method for the Simultaneous Determination of Florfenicol and Flunixin Meglumine Combination in an Injectable Solution

1Samih Darwazah Institute for Pharmaceutical Industries, Faculty of Pharmacy, Nursing and Health Professions, Birzeit University, West Bank, State of Palestine
2Department of Chemistry and Chemical Technology, Faculty of Science and Technology, Al-Quds University, Jerusalem 20002, State of Palestine

Correspondence should be addressed to Nidal Batrawi; moc.oohay@tabdin

Received 10 March 2017; Revised 25 May 2017; Accepted 13 June 2017; Published 11 July 2017

Academic Editor: Christos Kontoyannis

Copyright © 2017 Nidal Batrawi et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

The combination of the powerful antimicrobial agent florfenicol and the nonsteroidal anti-inflammatory flunixin meglumine is used for the treatment of bovine respiratory disease (BRD) and control of BRD-associated pyrexia, in beef and nonlactating dairy cattle. This study describes the development and validation of an HPLC-UV method for the simultaneous determination of florfenicol and flunixin, in an injectable preparation with a mixture of excipients. The proposed RP-HPLC method was developed by a reversed phase- (RP-) C18e (250 mm × 4.6 mm, 5 μm) column at room temperature, with an isocratic mobile phase of acetonitrile and water mixture, and pH was adjusted to 2.8 using diluted phosphoric acid, a flow rate of 1.0 mL/min, and ultraviolet detection at 268 nm. The stability-indicating method was developed by exposing the drugs to stress conditions of acid and base hydrolysis, oxidation, photodegradation, and thermal degradation; the obtained degraded products were successfully separated from the APIs. This method was validated in accordance with FDA and ICH guidelines and showed excellent linearity, accuracy, precision, specificity, robustness, LOD, LOQ, and system suitability results within the acceptance criteria.