Development and validation of an LC assay for sumatriptan succinate residues on surfaces in the manufacture of pharmaceuticals.
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.
Department of Analytical Chemistry, Faculty of Sciences, University of Valladolid, E-47005 Valladolid, Spain. mjdnozal@qa.uva.es
María J
MJ
Nozal
José L
JL
Bernal
L
L
Toribio
María T
MT
Martín
Francisco J
FJ
Diez
D002851:Chromatography, High Pressure Liquid / Q000379:methods / Q000706:statistics & numerical data; D018170:Sumatriptan / Q000032:analysis* / Q000737:chemistry; D013678:Technology, Pharmaceutical / Q000379:methods*
D018170:Sumatriptan