Development and validation of RP-HPLC method for simultaneous determination of ondansetron hydrochloride and granisetron hydrochloride in their admixtures with pantoprazole sodium

Abstract

Objective: Development of rapid and sensitive high performance liquid chromatography method for the quantification of ondansetron hydrochloride and granisetron hydrochloride in their admixtures with pantoprazole sodium in its dosage form using ketorolac tromethamine as internal standard. Materials and Methodology: Effective chromatographic separation of ondansetron hydrochloride or granisetron hydrochloride with pantoprazole sodium was achieved using Hypersil BDS-C18 column with isocratic elution of the mobile phase composed of acetonitrile: 10 mM acetate buffer: trimethylamine (20: 80: 0.5, v/v/v), pH 3.5. Detection was adjusted at dual wavelengths 290 and 305 nm for (pantoprazole sodium and ondansetron hydrochloride) or (pantoprazole sodium and granisetron hydrochloride), respectively. Results: The correlation coeffcient for pantoprazole sodium, ondansetron hydrochloride and granisetron hydrochloride were 0.9973, 0.9996 and 0.9988, respectively, limits of detection were 1.94, 1.21 and 0.67 μg/mL and limits of quantitation were 2.03, 3.66 and 5.90 μg/mL respectively, which indicated high sensitivity of the proposed method. Conclusion: The developed method can be used for quantification of ondansetron hydrochloride and granisetron hydrochloride in their admixtures with pantoprazole sodium in its dosage form.