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<p>Omeprazole (OMP), a member of proton pump inhibitors class, is widely used in the treatment of dyspepsia and peptic ulcer disease, etc. A simple, robust, and stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) method has been developed and validated for determination of OMP and its related substances. The analytes were separated on a short, fused core Halo octyl (C8) column (50&#xa0;mm × 2.1&#xa0;mm i.d., 2.7&#xa0;µm particle size) using a gradient elution at a column temperature of 25&#xa0;°C. Omeprazole and its related substances were monitored by UV detection at 280&#xa0;nm. Mobile phase A (MPA) of the method is 10&#xa0;mM ammonium acetate (NH<sub>4</sub>OAc) in H<sub>2</sub>O and mobile phase B (MPB) is MeOH/IPA (95/5). The total run time of the new method is 33&#xa0;min. The new HPLC method has a significantly higher degree of selectivity and efficiency in separating OMP related compounds compared with the current compendial HPLC methods for OMP drug substance outlined in the United States and European Pharmacopeia monographs.</p>

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Determination of Omeprazole and its Related Impurities in Bulk Drug Substance Batches by A Stability Indicating HPLC Method Based on a Short Octyl Fused Core Column

  • 期刊论文

  • 发表日期：

    2025年6月21日

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  • Renuka Rathnasekara,
  • Daoli Zhao,
  • Abu M. Rustum

摘要

Omeprazole (OMP), a member of proton pump inhibitors class, is widely used in the treatment of dyspepsia and peptic ulcer disease, etc. A simple, robust, and stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) method has been developed and validated for determination of OMP and its related substances. The analytes were separated on a short, fused core Halo octyl (C8) column (50 mm × 2.1 mm i.d., 2.7 µm particle size) using a gradient elution at a column temperature of 25 °C. Omeprazole and its related substances were monitored by UV detection at 280 nm. Mobile phase A (MPA) of the method is 10 mM ammonium acetate (NH4OAc) in H2O and mobile phase B (MPB) is MeOH/IPA (95/5). The total run time of the new method is 33 min. The new HPLC method has a significantly higher degree of selectivity and efficiency in separating OMP related compounds compared with the current compendial HPLC methods for OMP drug substance outlined in the United States and European Pharmacopeia monographs.