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目的:建立HPLC法测定茶新那敏片中马来酸氯苯那敏的含量及含量均匀度。方法:采用AglentC_(18)柱(150mm×4.6mm,5μm),以甲醇-0.01mol·L~(-1)磷酸二氢钾溶液-0.02mol·L~(-1)庚烷磺酸钠溶液(58.5:35.5:6)为流动相,柱温为30℃,流速1.0ml·min~(-1),检测波长为264nm。结果:马来酸氯苯那敏在20～120μg·ml~(-1)的范围内线性关系良好,r=0.9999,平均回收率103.6%,RSD为1.6%(n=6)。结论建议增加片中马来酸氯苯那敏的含量测定及含量均匀度检查。
Objective: To establish an HPLC method for the determination of content and uniformity of chlorphenamine maleate in Cha Xinnao Min tablets. METHODS: AglentC 18 column (150 mm × 4.6 mm, 5 μm) was used to elute a solution of 0.01 mol·L -1 potassium dihydrogen phosphate solution and 0.02 mol·L -1 heptane sulfonate solution (58.5: 35.5: 6) as the mobile phase. The column temperature was 30 ℃, the flow rate was 1.0 ml · min ~ (-1) and the detection wavelength was 264 nm. Results: Chlorphenamine maleate showed good linearity in the range of 20-120 μg · ml -1 with r = 0.9999, average recovery 103.6% and RSD 1.6% (n = 6). Conclusion It is suggested to increase the content of chlorpheniramine maleate in tablets and check the content uniformity.