A simple and fast ultra-high-performance liquid chromatography method with UV detection for the separation and quantification of omeprazole and the impurities of omeprazole and methylparaben (the internal standard) in six extemporaneous suspensions has been developed and fully validated. Isocratic elution was carried out using a Kinetex? C18 column, 50 × 2.1 mm packed with 1.7 μm porous shell particles, and the mobile phase comprised a mixture of phosphate buffer and acetonitrile. The separation of all compounds was achieved within 2 min. This method was successfully applied for stability evaluation of the developed formulations, which are now being used in the therapy of acid-related disorders in paediatric patients.
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机译：开发并充分验证了一种简便，快速的超紫外高效液相色谱法，用于分离和定量分析奥美拉唑以及奥美拉唑和对羟基苯甲酸甲酯（内标）中的杂质（内标）。使用Kinetex®进行等度洗脱。填充有1.7μm多孔壳颗粒的50×2.1 mm C18色谱柱，流动相包含磷酸盐缓冲液和乙腈的混合物。 2分钟内完成所有化合物的分离。该方法已成功用于开发制剂的稳定性评估，该制剂现已用于儿科患者的酸相关疾病的治疗。
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