A validated stability-indicating HPLC method for routine analysis of an injectable lincomycin and spectinomycin
Murad N Abualhasan1, Nidal Batrawi, Oliver B Sutcliffe
1Department of Pharmacy, An-Najah National University, Nablus, Palestine.
Scientia Pharmaceutica
|December 25, 2012
Summary
A new HPLC method accurately analyzes lincomycin and spectinomycin injectable veterinary drugs. This validated method ensures drug quality and can assess purity and degradation.
Area of Science:
- Analytical Chemistry
- Veterinary Pharmacology
Background:
- Lincomycin and spectinomycin are crucial for treating animal gastrointestinal and respiratory infections.
- Accurate analysis of these veterinary drugs is essential for ensuring treatment efficacy and safety.
Purpose of the Study:
- To develop and validate a simple, reverse-phase High-Performance Liquid Chromatography (HPLC) method for analyzing injectable lincomycin and spectinomycin preparations.
- To establish a stability-indicating method for purity and degradation evaluation.
Main Methods:
- Reverse-phase HPLC using an RP-C(18) column.
- Gradient elution with acetonitrile and a phosphate buffer (pH 6).
- UV detection at 220 nm, with a flow rate of 1 mL/min.
Main Results:
- The developed HPLC method demonstrated excellent linearity, accuracy, precision, and selectivity.
- Validation according to FDA and ICH guidelines confirmed the method's suitability.
- The method proved effective for purity and degradation studies, indicating its stability-indicating nature.
Conclusions:
- A robust and validated HPLC method for lincomycin and spectinomycin analysis in veterinary formulations has been established.
- This method is suitable for routine quality control, purity assessment, and stability studies of these important veterinary drugs.
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