Validation Changes to the USP Assay Method for Ibuprofen Tablets

Changes were made to the USP method for the preparation of assay samples of ibuprofen (IBP) tablets (1). These changes included extraction and filtration techniques during sample preparation and required validation for the quantitation of IBP in assay samples. In this article, which is the first in a series about the validation of changes to the USP IBP assay method, we describe the validation of sample extraction and filtration techniques. Specifically, the extraction and filtration validation addresses the following:
● the effect of direct extraction (versus the powdering of tablets
and extraction or the shaking of coated tablets with glass beads
as per USP method) and shaking time on the disintegration
of tablets in extraction solvent and the solubilization of the
active ingredient as determined by the recovery of IBP from
tablets
● the effect of filtration (versus a centrifugation technique as
per the USP method) of extracts on the recovery of IBP from
tablet assay preparations.

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