A validated and Stability Indicating HPLC Method for Analysis of Diminazene Aceturate and Antipyrine Combination in a Ready Injectable Solution

M_abualhasan's picture
Journal Title, Volume, Page: 
Drug Res (Stuttg) 2013; 63(06): 300-304 DOI: 10.1055/s-0033-1337939
Year of Publication: 
2013
Authors: 
M. N. Abualhasan
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
N. Batrawi
Advanced Veterinary Company, Ramallah, Palestine
A. N. Zaid
Department of Pharmacy, An-Najah National University, Nablus, Palestine
D. G. Watson
Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK
Preferred Abstract (Original): 

Diminazene aceturate and Antipyrine combination therapy is widely used in veterinary medicine. A simple reverse HPLC method for the analysis of samples of a ready injectable formulation containing a mixture of active ingredients and inactive excipients has been developed. The HPLC analysis was carried out using a reversed phase (RP)-C18 (250 mm×4.0 mm, 5 μm) column. The isocratic mobile phase consisted of a mixture of acetonitrile, methanol, phosphate buffer and hexane sulfonate; the flow rate was 0.6 mL/min and ultraviolet detection was at 291 nm. This method was validated in accordance with FDA and ICH guidelines and showed good linearity, accuracy, precision, selectivity and the system suitability results were within the acceptance criteria. A stability-indicating study was also carried out and indicated that this method could be used for purity and degradation evaluation of these formulations.