Performance Verification of the USP Mometasone Furoate Ointment Method Using the Alliance HPLC System

Importance of the Topic

Verifying compendial methods for topical formulations is essential in pharmaceutical quality control to ensure patient safety and regulatory compliance. The USP monograph for mometasone furoate ointment defines system suitability requirements that must be met by an HPLC system to deliver accurate, precise, and reproducible results under cGMP conditions.

Objectives and Study Overview

This study aimed to demonstrate the performance of the USP mometasone furoate ointment assay using the Alliance® HPLC System. Key goals included:

• Assessing reproducibility of retention time and peak area
• Evaluating system suitability parameters against USP acceptance criteria
• Confirming the suitability of the Alliance HPLC System for routine QC analyses

Methodology and Instrumentation

The assay was performed according to the USP monograph for mometasone furoate ointment. Analytical solutions were prepared as specified in the compendial method. Chromatographic separation employed an XBridge™ Shield RP18 column (4.6 × 250 mm, 5 µm) guided by Waters’ reversed-phase selectivity chart. Instrumentation details:

• Alliance HPLC System equipped with quaternary solvent delivery
• Waters 2489 UV/Visible detector operated at the USP-specified wavelength
• Column temperature and injection parameters set per monograph recommendations

Main Results and Discussion

The Alliance system delivered baseline separation of mometasone furoate and internal standard (diethyl phthalate). System suitability was evaluated over five replicate standard injections. Key results included:

• Tailing factor: measured 1.03 (USP NMT 1.5)
• Retention time RSD: 0.04% (USP NMT 2.0%)
• Peak area RSD: 0.19% (USP NMT 2.0%)

All parameters were well within USP limits, confirming excellent precision and consistent solvent delivery. Low variability in retention time and peak area indicates robust performance and minimal downtime due to system maintenance.

Benefits and Practical Applications

Implementation of this verified method on the Alliance HPLC System offers several advantages:

• High reproducibility minimizes re-runs and increases laboratory throughput
• Reliable solvent delivery and precise temperature control ensure consistent results
• Compliance with USP system suitability criteria supports regulatory audits and cGMP adherence

Future Trends and Opportunities

Emerging directions and potential enhancements include:

• Integration of automated sample preparation to further reduce manual steps
• Application of similar verification workflows to other corticosteroid or complex formulations
• Coupling HPLC with mass spectrometry detectors for enhanced specificity and identification
• Adoption of data-handling software platforms to streamline QC reporting

Conclusion

The Alliance HPLC System reliably meets USP requirements for the mometasone furoate ointment assay, delivering excellent reproducibility and system suitability performance. This robustness supports routine pharmaceutical QC operations by reducing downtime and ensuring consistent analytical throughput.