Analysis of Roxatidine Acetate Hydrochloride

Importance of the Topic

Roxatidine acetate hydrochloride is a histamine H2-receptor antagonist widely used to treat gastrointestinal disorders. Reliable quantification and dissolution testing of this active pharmaceutical ingredient are essential for ensuring drug efficacy, safety, and regulatory compliance. A robust HPLC method supports quality control in both research and manufacturing environments.

Objectives and Study Overview

This study aims to establish a simple, rapid, and reproducible reversed-phase HPLC method for the analysis of roxatidine acetate hydrochloride. Key goals include achieving sharp peak shape, adequate resolution, and a run time compatible with high-throughput dissolution testing.

Methodology

The method employs an isocratic elution with a mobile phase composed of water, acetonitrile, triethylamine, and acetic acid in the ratio 340 : 60 : 2 : 1. The column temperature is held at 40 °C and the flow rate at 0.8 mL/min. Sample injection volume is 20 µL and detection is carried out at 274 nm. Total analysis time is under 7 minutes, ensuring efficiency for routine assays.

Used Instrumentation

• HPLC System: Nexera™ FV
• Column: Shim-pack™ VP-ODS (150 mm × 4.6 mm I.D., 5 µm)
• Vials: Shimadzu glass vials, LC, 1.1 mL
• Detector: UV at 274 nm

Results and Discussion

The chromatogram shows a single, well-resolved peak for roxatidine acetate hydrochloride with symmetric shape and retention time suitable for dissolution testing. Baseline stability and absence of interfering peaks confirm method specificity. Consistent peak area responses underline method precision.

Benefits and Practical Applications

• Fast analysis time supports high sample throughput in quality control labs.
• Isocratic conditions simplify method setup and maintenance.
• Low organic solvent consumption aligns with cost-efficiency and green chemistry principles.
• Robust performance makes it suitable for routine dissolution and content uniformity tests.

Future Trends and Opportunities

Advances in ultra-high-performance liquid chromatography could further reduce run times and solvent use. Integration with mass spectrometric detection may enhance sensitivity for trace impurity profiling. Automation and online dissolution coupling offer prospects for real-time monitoring of drug release kinetics.

Conclusion

A straightforward, reproducible HPLC method for roxatidine acetate hydrochloride has been developed using Shim-pack VP-ODS and Nexera FV. The protocol delivers rapid, reliable results suitable for pharmaceutical quality control and dissolution studies.

References

Shimadzu Corporation. Application News 01-00029 (JP), First Edition Dec 2021.© Shimadzu Corporation, 2021