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Analysis of doxycycline by capillary electrophoresis. Method development and validation
E C Gil1, A Van Schepdael, E Roets
1Centro de Química Farmacéutica, Havana, Cuba.
Journal of Chromatography. A
|December 6, 2000
Summary
An optimized capillary electrophoresis method accurately analyzes doxycycline. This validated technique offers high selectivity, repeatability, and sensitivity for pharmaceutical quality control.
Area of Science:
- Analytical Chemistry
- Separation Science
- Pharmaceutical Analysis
Background:
- Accurate quantification of doxycycline is crucial for pharmaceutical quality control.
- Existing analytical methods may require optimization for improved efficiency and sensitivity.
Purpose of the Study:
- To develop and optimize a capillary electrophoresis (CE) method for doxycycline analysis.
- To systematically investigate key method parameters for enhanced separation performance.
Main Methods:
- Capillary electrophoresis with systematic investigation of methanol concentration, buffer pH and concentration, capillary dimensions, temperature, and additives (Triton X-100, methyl-beta-cyclodextrin).
- Central composite design employed for efficient method optimization.
- Analysis of six commercial doxycycline samples.
Main Results:
- Optimal separation conditions identified: uncoated fused-silica capillary, specific background electrolyte composition (145 mM sodium carbonate, 1 mM EDTA, pH 10.3), 11% methanol, 15°C, and 12 kV.
- The optimized CE method demonstrated excellent selectivity, repeatability, linearity, and sensitivity.
- Quantitative analysis of commercial samples showed comparable results to the European Pharmacopoeia liquid chromatography method.
Conclusions:
- The developed capillary electrophoresis method provides a robust and efficient analytical tool for doxycycline.
- This optimized CE technique offers a viable alternative for pharmaceutical quality control, meeting stringent analytical requirements.