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目的:建立洛索洛芬钠的含量及其有关物质的反相高效液相色谱测定方法。方法:采用Kromasil-C_(18)色谱柱(250mm×4.6mm,5μm),以乙腈-水(40∶60,10%磷酸溶液调pH=3.5)为流动相,流速为1.0mL·min~(-1),检测波长为222nm。结果:建立的色谱方法使有关物质与主药分离良好,洛索洛芬钠在5.096～45.864μg·mL~(-1)范围内,浓度与峰面积线性关系良好。结论:本法简便、准确,可用于洛索洛芬钠的含量测定及其有关物质的测定。
Objective: To establish a method for the determination of loxoprofen sodium and its related substances by reversed-phase high performance liquid chromatography. METHODS: Kromasil-C 18 column (250 mm × 4.6 mm, 5 μm) was used as the mobile phase with acetonitrile-water (40:60, 10% phosphoric acid solution adjusted to pH 3.5) at a flow rate of 1.0 mL · min ~ -1), detection wavelength of 222nm. Results: The chromatographic method was established to separate the related substances from the main drug. The concentration of loxoprofen sodium was in the range of 5.096 ~ 45.864μg · mL ~ (-1), and the linear relationship between concentration and peak area was good. Conclusion: This method is simple, accurate and can be used for the determination of loxoprofen sodium and its related substances.