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目的:建立高效液相色谱法测定富马酸卢帕他定片剂含量及有关物质的方法。方法:色谱柱:Dimonsil C_(18)(200 mm×4.6 mm,5μm);流动相:甲醇-2.5 mmol·L~(-1)庚烷磺酸钠溶液(75:25);柱温:30℃;检测波长:247 nm;流速:1.0 ml·min~(-1)。结果:富马酸卢帕他定的线性范围为0.026 6～0.424 8 mg·ml~(-1)(r=0.999 9),平均回收率为100.2%(RSD=0.9%,n=9),片剂中有关物质的含量<1%。结论:建立的方法操作简单、结果准确、专属性强、重复性好,可用于富马酸卢帕他定片剂中有关物质检查及主药含量测定。
Objective: To establish a HPLC method for the determination of rupatadine fumarate tablets and related substances. Methods: The chromatographic column was Dimonsil C18 (200 mm × 4.6 mm, 5 μm). The mobile phase was methanol-2.5 mmol·L -1 heptanesulfonate solution (75:25). The column temperature was 30 ℃; detection wavelength: 247 nm; flow rate: 1.0 ml · min ~ (-1). Results: The linear range of rupatadine fumarate was 0.026 6-0.424 8 mg · ml -1 (r = 0.999 9), the average recovery was 100.2% (RSD = 0.9%, n = 9) Related substances in tablets <1%. Conclusion: The established method has the advantages of simple operation, accurate results, strong specificity and good reproducibility. It can be used for the related substances examination and the determination of the main drug in rupatadine fumarate tablets.