A Validated Stability-Indicating HPLC Method for Routine Analysis of an Injectable Lincomycin and Spectinomycin Formulation

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Journal Title, Volume, Page: 
Sci. Pharm. 2012; 80: 977–986
Year of Publication: 
2012
Authors: 
Murad N. ABUALHASAN
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Nidal BATRAWI
Advanced Veterinary Company, Ramallah, Palestine
Oliver B. SUTCLIFFE
Division of Chemistry & Environmental Science, School of Science and the Environment, Manchester Metropolitan University, Manchester, United Kingdom
Abdel Naser ZAID
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
Preferred Abstract (Original): 

Lincomycin and spectinomycin combination therapy is widely used in veterinary medicine for the treatment of gastrointestinal and respiratory infections caused by lincomycin- and spectinomycin-sensitive microorganisms. A simple, reverse phase HPLC method for the analysis of samples of an injectable lincomycin and spectinomycin preparation containing a mixture of inactive excipients has been developed. The HPLC was carried out using the RP-C18 (250 mm × 4.0 mm, 5 μm) column, with the gradient mobile phase consisting of an acetonitrile and phosphate buffer at pH 6; the flow rate of 1 mL/min and ultraviolet detection at 220 nm. This method was validated in accordance with both FDA and ICH guidelines and showed good linearity, accuracy, precision, selectivity, and system suitability results within the acceptance criteria. A stability-indicating study was also carried out and indicated that this method can also be used for purity and degradation evaluation of these formulations.

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