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目的:建立HPLC法测定酚氨咖敏片中马来酸氯苯那敏含量均匀度的方法。方法:高效液相色谱法。色谱柱:LunaC18柱(4.6mm×250mm,5μm);流动相:1%醋酸溶液(用二乙胺调节pH值至3.7)-甲醇(62∶38);流速:1.0mL·min-1;检查检测波长:260nm,柱温30℃;进样量:20μL;结果:在进样量0.1007μg～3.2211μg范围内,氯苯那敏色谱峰的峰面积呈良好的线性关系,r=0.9999(n=6),平均回收率(n=9)为99.37%(RSD为0.33%)。结论:本法专属性和准确性好,可用于酚氨咖敏片中马来酸氯苯那敏含量均匀度的检查。
OBJECTIVE: To establish a method for the determination of chlorphenamine maleate uniformity in phenamme sodium tablets by HPLC. Methods: High performance liquid chromatography. Column: Luna C18 column (4.6 mm × 250 mm, 5 μm); mobile phase: 1% acetic acid solution (adjusted to pH 3.7 with diethylamine) -methanol (62:38); flow rate: 1.0 mL · min -1; The detection wavelength was 260nm, the column temperature was 30 ℃, and the injection volume was 20μL. RESULTS: The peak areas of chlorpheniramine peak showed a good linearity in the range of 0.1007μg ~ 3.2211μg, r = 0.9999 (n = 6), the average recovery (n = 9) was 99.37% (RSD 0.33%). Conclusion: The specificity and accuracy of this method is good, and it can be used to check the content uniformity of chlorphenamine maleate in phenylalocarbene tablets.