Analysis of Cefradine

Importance of the Topic

The accurate analysis of cefradine and related cephalosporin antibiotics is critical for ensuring the safety and efficacy of pharmaceutical products. Reliable quantification supports regulatory compliance, quality assurance, and therapeutic monitoring in both manufacturing and clinical environments.

Objectives and Study Overview

This work aims to establish a robust reversed-phase HPLC method for the simultaneous separation and quantification of cefradine and cephalexin. The study focuses on optimizing chromatographic parameters to achieve clear resolution, consistent retention times, and reproducible peak shapes.

Methodology

The separation was performed on a Shim-pack VP-ODS column (250 mm x 4.6 mm I.D., 5 µm) at 40°C. The mobile phase consisted of water, methanol, 3.86% sodium acetate solution, and 4% acetic acid in a ratio of 1564:400:30:6 by volume. A flow rate of 0.9 mL/min and an injection volume of 10 µL were used. Detection was achieved with a UV detector set to 254 nm.

Used Instrumentation

• Shim-pack VP-ODS column (P/N 228-34937-92)
• High-performance liquid chromatography system with UV detection at 254 nm
• LabTotal vial for LC/LCMS (P/N 227-34001-01)

Main Results and Discussion

The optimized method delivered baseline separation between cephalexin (first eluting) and cefradine. Both analytes exhibited sharp, symmetrical peaks with reproducible retention times across repeated injections. The chromatogram of the standard mix confirmed the method’s precision and stability under the selected conditions.

Benefits and Practical Applications of the Method

• High specificity and sensitivity for cephalosporin antibiotics
• Rapid analysis time compatible with high-throughput workflows
• Suitable for pharmaceutical quality control and clinical laboratory testing

Future Trends and Potential Applications

Future developments may include coupling with mass spectrometry for enhanced sensitivity and selectivity, automation of sample preparation to increase throughput, and adoption of more eco-friendly mobile phases in line with green chemistry initiatives.

Conclusion

The described reversed-phase HPLC method is a reliable and efficient tool for the analysis of cefradine and cephalexin. Its robust performance and ease of implementation make it well suited for routine quality control in pharmaceutical and clinical settings.