A validated and stability indicating HPLC method for analysis of diminazene aceturate and antipyrine combination in a ready injectable solution.
Drug Res (Stuttg)
; 63(6): 300-4, 2013 Jun.
Article
in En
| MEDLINE
| ID: mdl-23532624
ABSTRACT
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Trypanocidal Agents
/
Anti-Inflammatory Agents, Non-Steroidal
/
Antipyrine
/
Chromatography, High Pressure Liquid
/
Diminazene
Type of study:
Guideline
Language:
En
Journal:
Drug Res (Stuttg)
Year:
2013
Document type:
Article