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Method development and validation for the analysis of meloxicam in tablets by CZE
1Department of Analytical Chemistry, Faculty of Pharmacy, University of Hacettepe, 06100 Ankara, Turkey. enemutlu@hacettepe.edu.tr
Journal of Pharmaceutical and Biomedical Analysis
|March 1, 2003
Summary
A new capillary zone electrophoresis method accurately analyzes meloxicam in pharmaceuticals. This validated assay offers high precision and sensitivity for drug quality control.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Meloxicam is a widely used nonsteroidal anti-inflammatory drug (NSAID).
- Accurate quantification of meloxicam in pharmaceutical formulations is crucial for quality control and patient safety.
Purpose of the Study:
- To develop and validate a capillary zone electrophoresis (CZE) assay for the quantitative analysis of meloxicam.
- To optimize CZE parameters for enhanced separation and detection of meloxicam.
Main Methods:
- Systematic investigation of buffer concentration, pH, methanol percentage, capillary temperature, applied voltage, and injection time.
- Optimization was performed using a fused silica capillary with hydrodynamic injection.
- Diflunisal was employed as the internal standard, and detection was set at 205 nm.
Main Results:
- Optimal conditions included 100 mM borate buffer (pH 8.5), 5% methanol, 25°C capillary temperature, 20 kV applied voltage, and 3 s injection time.
- The validated method demonstrated excellent selectivity, accuracy, precision, linearity, and sensitivity.
- Analysis of six pharmaceutical preparations, including two dosage forms, yielded relative standard deviations below 0.66%.
Conclusions:
- The developed capillary zone electrophoresis assay is a reliable and efficient method for meloxicam determination.
- The method's performance was statistically comparable to a literature-reported spectrophotometric method.
- This CZE assay is suitable for routine quality control of meloxicam in pharmaceutical products.