Analysis of Omeprazole within JP Methods (Test for Required Detectability)

Significance of the Topic

Omeprazole is a widely prescribed proton‐pump inhibitor used to manage gastric acid–related disorders. Ensuring its consistent potency and purity is critical for patient safety and regulatory compliance. High‐performance liquid chromatography (HPLC) methods that meet pharmacopeial detectability requirements provide pharmaceutical manufacturers and quality control laboratories with reliable tools for routine analysis.

Objectives and Study Overview

This application report demonstrates the suitability of a reversed‐phase Shim‐pack GIST C8 column for the Japanese Pharmacopeia (JP) test of omeprazole detectability. The study aims to verify that the method can accurately quantify omeprazole at regulatory threshold concentrations (5 mg/L and 1 mg/L) while maintaining resolution and sensitivity.

Methodology and Instrumentation

The analysis was conducted on a Prominence‐i HPLC system equipped with a Shim‐pack GIST C8 column (150 mm × 4.6 mm I.D., 5 μm). Key chromatographic conditions:

• Mobile phase: Phosphate buffer (pH 7.6) and acetonitrile (29:11, v/v)
• Flow rate: 1.3 mL/min
• Column temperature: 25 °C
• Injection volume: 10 μL
• Detection: UV at 280 nm (cell temperature 40 °C)

Main Results and Discussion

Calibration standards at 5 mg/L and 1 mg/L produced well‐defined peaks with minimal tailing and baseline noise. The method delivered reproducible retention times and peak areas, confirming detectability at the JP threshold. Chromatograms showed a single symmetric peak for omeprazole, indicating adequate selectivity under the chosen conditions.

Benefits and Practical Applications

• Robust quantification of omeprazole at low concentrations
• Compliance with JP detectability criteria
• High throughput with a short analysis cycle
• Minimal method development due to standardized reagents and column chemistry

Future Trends and Potential Applications

Advances in column technology and detection methods, such as coupling with mass spectrometry, are expected to further enhance sensitivity and specificity. Green chromatography approaches, including reduced solvent consumption and alternative buffer systems, may become more prevalent in pharmaceutical analysis. Integration with automated sampling and data evaluation platforms will streamline routine testing workflows.

Conclusion

The Shim‐pack GIST C8 column, paired with the specified mobile phase and detection settings, meets the JP requirements for omeprazole detectability. This method offers a reliable, reproducible, and efficient solution for pharmaceutical quality control laboratories.

References

• Application News L494 (Japan, English) Shimadzu Corporation, First Edition Dec. 2021. ERAS-1000-0104.