Validation of a liquid chromatographic method for the determination of ranitidine hydrochloride residues on surfaces in the manufacture of pharmaceuticals.
A liquid chromatographic method for determination of the residues of ranitidine hydrochloride on various surfaces employed in drug manufacture is described. Cotton swabs, moistened with a methanol-water (1:1, v/v) mixture were used to remove any residues of drugs from glass, vinyl, and stainless steel surfaces, and gave recoveries of 85%, 78% and 90%, respectively. Residues were determined by high-performance liquid chromatography on a C18 column at 25 degrees C with methanol-ammonium acetate (40:60 v/v) pH 6.7 as the mobile phase and detection at 320 nm. The method was validated over a concentration range of 20-10 000 ng/ml and had a detection limit of 2 ng/ml.
Nozal
M J
MJ
Department of Analytical Chemistry, Faculty of Sciences, University of Valladolid, Spain. mjdnozal@qa.uva.es
Bernal
J L
JL
Toribio
L
L
Martín
M T
MT
Diez
F J
FJ
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004345:Drug Industry; D006635:Histamine H2 Antagonists / Q000032:analysis*; D011899:Ranitidine / Q000032:analysis*
D006635:Histamine H2 Antagonists; D011899:Ranitidine