Determination of Cefadroxil in Tablet/Capsule formulations by a validated Reverse Phase High Performance Liquid
Najia Rahim1, Syed Baqir-Shyum Naqvi2, Sadia Shakeel
1Department of Pharmaceutics, Dow College of Pharmacy, Dow University of Health Sciences, Karachi, Pakistan.
Pakistan Journal of Pharmaceutical Sciences
|July 6, 2015
Summary
A new, rapid reversed-phase High-Performance Liquid Chromatography (RP-HPLC) method accurately analyzes cefadroxil in bulk materials and oral solid dosage forms. This validated method is suitable for quality control laboratories.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Cefadroxil is an important antibiotic requiring robust analytical methods for quality control.
- Existing analytical methods may lack the required selectivity, speed, or cost-effectiveness for routine analysis.
Purpose of the Study:
- To develop and validate an innovative, selective, and rapid RP-HPLC method for cefadroxil analysis.
- To ensure the method is suitable for routine quality control (QC) and quality assurance (QA) of cefadroxil raw materials and oral solid dosage forms.
Main Methods:
- Utilized a reversed-phase High-Performance Liquid Chromatography (RP-HPLC) system with a C18 column.
- Employed a mobile phase of methanol: Phosphate buffer (10:90) at a flow rate of 1.5 ml/min.
- Validated the method for linearity, reproducibility, repeatability, limit of detection (LOD), and limit of quantitation (LOQ).
Main Results:
- The developed RP-HPLC method demonstrated excellent linearity (R²=0.9935).
- High reproducibility and repeatability were confirmed with %RSD values within acceptable ranges (intra-day: 1.75-5.33%, inter-day: 0.58-2.69%).
- The method achieved a low LOD of 0.5 μg/ml and LOQ of 1.0 μg/ml, indicating high sensitivity.
Conclusions:
- The developed RP-HPLC method is sensitive, accurate, precise, rapid, and cost-effective.
- This method is highly efficient for the routine analysis of cefadroxil in both bulk material and oral solid dosage formulations.
- The validated method can be effectively implemented in QC/QA laboratories for ensuring cefadroxil product quality.
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