Increasing Efficiency of Method Validation for Metoclopramide HCl and Related Substances with Empower 3 MVM Software

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Margaret Maziarz, Mark Wrona, and Sean M. McCarthy
Waters Corporation
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Application Notes
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In this application note, we demonstrate the validation of a UPLC method for related substances of metoclopramide HCl for linearity, detection and quantitation limits, accuracy, repeatability, intermediate precision, specificity, and robustness using Empower 3 Method Validation Manager. Validation results showed that the method is linear, accurate, repeatable, precise, specific, and robust for all related substances tested in this study. The quantitation limit of all related compounds was below the reporting threshold of 0.1% or 0.5 μg/mL.

Empower 3 MVM software streamlined the entire validation process, from creating a validation protocol method to acquiring, reviewing, analyzing, approving, and reporting validation data. The updated tool/message center provided status of each validation test in a study and whether the results met the acceptance criteria, and flagged any out-of-specification results. Using ApexTrack for automated peak integration enabled consistent integration of all peaks during the validation process. Using the ACQUITY QDa Detector for mass detection in conjunction with UV detection enabled quick determination of peak purity using mass and UV spectral data. Finally, the validation results and validation study were reviewed and approved via electronic signatures.

Empower 3 MVM is compliant-ready software that can be easily adapted by any analytical laboratory to improve efficiency of the chromatographic method validation process and to ensure conformance to validation requirements.

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