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 raniti dine hydrochloride on various surfaces employed in drug manufacture is desc ribed. 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 stee l surfaces, and gave recoveries of 85%, 78% and 90%, respectively. Residues were determined by high-performance liquid chromatography on a C-18 column at 25 degreesC with methanol-ammonium acetate (40:60 v/v) pH 6.7 as the mo bile phase and detection at 320 nm. The method was validated over a concent ration range of 20-10 000 ng/ml and had a detection limit of 2 ng/ml. (C) 2 001 Elsevier Science B.V. All rights reserved.