HPLC Determination of Ondansetron-Atropine and Ondansetron-Glycopyrrolate Mixtures in 0.9% Sodium Chloride Injection

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Abstract
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 μg/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 μg/mL, respectively, based on a signal to noise ratio of 3 and a 20 μL 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 μg/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 μg/mL, respectively, based on a signal to noise ratio of 3 and a 20 μL injection.