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

IF 1.3 4区化学 Q4 BIOCHEMICAL RESEARCH METHODS

Chromatographia Pub Date : 2025-06-21 DOI:10.1007/s10337-025-04418-3

Renuka Rathnasekara, Daoli Zhao, Abu M. Rustum

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Abstract

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.

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基于短辛烷熔芯柱的稳定性指示高效液相色谱法测定原料药中奥美拉唑及其相关杂质

奥美拉唑（OMP）是质子泵抑制剂类的一员，广泛用于治疗消化不良、消化性溃疡等疾病。建立了一种简便、可靠、稳定性好的反相高效液相色谱法（RP-HPLC），并对其进行了验证。在25℃的柱温下，采用梯度洗脱，将分析物在短熔芯Halo辛烷（C8）柱（50 mm × 2.1 mm，粒径2.7µm）上分离。采用280 nm紫外分光光度法对奥美拉唑及其有关物质进行监测。该方法的流动相A （MPA）为10 mM醋酸铵（NH4OAc），流动相B （MPB）为MeOH/IPA（95/5）。新方法的总运行时间为33分钟。与现行美国和欧洲药典专著中概述的OMP原料药的药典HPLC方法相比，该方法对OMP相关化合物的分离选择性和效率显著提高。

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来源期刊

Chromatographia 化学-分析化学

CiteScore

3.40

自引率

5.90%

发文量

103

审稿时长

2.2 months

期刊介绍： Separation sciences, in all their various forms such as chromatography, field-flow fractionation, and electrophoresis, provide some of the most powerful techniques in analytical chemistry and are applied within a number of important application areas, including archaeology, biotechnology, clinical, environmental, food, medical, petroleum, pharmaceutical, polymer and biopolymer research. Beyond serving analytical purposes, separation techniques are also used for preparative and process-scale applications. The scope and power of separation sciences is significantly extended by combination with spectroscopic detection methods (e.g., laser-based approaches, nuclear-magnetic resonance, Raman, chemiluminescence) and particularly, mass spectrometry, to create hyphenated techniques. In addition to exciting new developments in chromatography, such as ultra high-pressure systems, multidimensional separations, and high-temperature approaches, there have also been great advances in hybrid methods combining chromatography and electro-based separations, especially on the micro- and nanoscale. Integrated biological procedures (e.g., enzymatic, immunological, receptor-based assays) can also be part of the overall analytical process.