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目的:采用高效液相色谱法测定富马酸氯马斯汀及片剂中的有关物质和降解产物。方法:采用ODS-3 C18色谱柱(250mm×4.6 mm,5μm);柱温为35℃;流动相为乙腈-辛烷磺酸钠溶液(50∶50);流速为1.0 mL.min-1;检测波长为210 nm;进样量为10μL。结果:各降解产物、辅料均可与富马酸氯马斯汀主峰良好分离,方法的精密度和重复性良好(RSD<0.3%)。结论:经方法学验证,该法灵敏、准确,适用于富马酸氯马斯汀及片剂中有关物质的测定。
Objective: To determine the related substances and degradation products of clemastine fumarate and tablets by high performance liquid chromatography. Methods: ODS-3 C18 column (250 mm × 4.6 mm, 5 μm) was used. The column temperature was 35 ℃. The mobile phase was acetonitrile-octane sulfonate solution (50:50) The detection wavelength was 210 nm; injection volume was 10 μL. Results: All degradation products and excipients were well separated from the main peak of clemastine fumarate. The precision and reproducibility of the method were good (RSD <0.3%). Conclusion: The method is validated by the method and is sensitive and accurate. It is suitable for the determination of clemastine fumarate and related substances in tablets.