HPLC法测定富马酸氯马斯汀及富马酸氯马斯汀片的有关物质

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(250 mm×4.6 mm,5 μm);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10 μL。 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: High performance liquid chromatography method was established to determine the related substances and the degradation substances in clemastine fumarate ant its tablets. Methods: An ODS-3 C₁₈ column(250 mm×4.6 mm,5 μm)with UV detection at 210 nm,and acetonitrile-sodium octanesulfonate solution (50:50) as the mobile phase were used in HPLC.The flow rate was 1.0 mL·min^-1,and the temperature of the column was 35 ℃. Results: An excellent separation was achieved for clemastine fumarate,excipient and its related substances.The reproducibility and precision of the method were good(RSD<0.3%). Conclusion: This method was accurate,simple,quick and effective for determination of related substances and the degradation substances in clemastine fumarate tablets.It was also suitable for the quality control for clemastine fumarate and its tablets.