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Journal of pharmaceutical and biomedical analysis

Development and validation of an LC assay for sumatriptan succinate residues on surfaces in the manufacture of pharmaceuticals.


PMID 12191714

Abstract

A high performance liquid chromatographic (HPLC) method for the assay of sumatriptan succinate residues in swabs collected from manufacturing equipment surfaces was developed and validated in order to control a cleaning procedure. The swabbing procedure using two cotton swabs moistened with water was validated applying a wipe-test and a HPLC method developed to determine low quantities of the drug. The HPLC method involves a C18 column at 25 degrees C, a mixture of ammonium phosphate monobasic (0.05 M)-acetonitrile (84:16, v/v) as a mobile phase and UV detection at 228 nm. Using the proposed method, the average recoveries obtained are of 88.5% for vinyl, 94.2% for glass and 95.2% for stainless steel plates with RSD of 5.5 (n=36), 2.3 (n=36), 2.2% (n=36), respectively. The method was successfully applied to the assay of real swab samples collected from the equipment surfaces.

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