HPLC DETERMINATION OF ONDANSETRON-ATROPINE AND ONDANSETRON-GLYCOPYRROLATE MIXTURES IN 0.9-PERCENT SODIUM CHLORIDE INJECTION

摘要

High Performance Liquid Chromatography procedures have been developed for the assay of ondansetron-atropine and ondansetron-glycopyrrolate mixtures in 0.9% sodium chloride injection. The separation and quantitation of the ondansetron-atropine mix was achieved on an octylsilane column at ambient temperature using a mobile phase of 60:40 v/v 0.01 M phosphate buffer, pH 4-acetonitrile at a flow rate of 1.0 mL/min with detection of the analytes at 254 nm. The separation is achieved within 15 min. The method showed linearity for ondansetron and atropine in the 266-1332 and 28-138 mu g/mL ranges, respectively. Accuracy and precision were in the 0.2-5.6% and 0.4-1.8% ranges, respectively, for both drugs. The limits of detection for ondansetron and atropine were 2.1 ng/mL and 8.6 mu g/mL, respectively, based on a signal to noise ratio of 3 and a 20 mu L injection. The separation and quantitation of the ondansetron-glycopyrrolate mix was achieved on an octylsilane column at ambient temperature using a mobile phase of 55:45 v/v 0.01 M phosphate buffer, pH 4- acetonitrile at a flow rate of 1.0 mL/min with detection of the analytes at 254 nm. The separation is achieved within 15 min. The method showed linearity for ondansetron and glycopyrrolate in the 500-2000 and 50-200 mu g/mL ranges, respectively. Accuracy and precision were in the 2.5-3.7% and 0.1-1.5% ranges, respectively, for both analytes. The limits of detection for ondansetron and glycopyrrolate were 90 ng/mL and 6.9 mu g/mL, respectively, based on a signal to noise ratio of 3 and a 20 mu L injection.