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目的:建立鼻泰片中马来酸氯苯那敏的含量测定方法。方法:采用HPLC法,选用Kromasil C_(18)色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.3%十二烷基硫酸钠溶液-磷酸(65:35:0.02),流速1.0 ml·min~(-1),检测波长262 nm。柱温为25℃。结果:马来酸氯苯那敏在0.260～2.084μg范围内线性关系良好(r=0.999 1),平均加样回收率为97.30%,RSD为1.33%(n=5)。结论:方法简便可靠,可用于鼻泰片的质量控制。
Objective: To establish a method for the determination of chlorphenamine maleate in Nantai Tablets. Methods: The mobile phase consisted of acetonitrile - 0.3% sodium dodecyl sulfate solution - phosphoric acid (65:35:.02) with a mobile phase of 1.0 with Kromasil C 18 column (250 mm × 4.6 mm, ml · min ~ (-1) and detection wavelength was 262 nm. The column temperature was 25 ° C. Results: The linear range of chlorpheniramine maleate was 0.260 ~ 2.084μg (r = 0.999 1). The average recovery was 97.30% and the RSD was 1.33% (n = 5). Conclusion: The method is simple and reliable, which can be used for the quality control of nasal tablets.