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目的:建立HPLC法测定抗过敏类健康产品中非法添加的马来酸氯苯那敏含量。方法:采用Diamonsil C18(4.6mm×250mm,5μm)色谱柱,以0.05mol/L磷酸二氢钾溶液(含1%三乙胺和0.005mol/L的庚烷磺酸钠,用磷酸调节pH至3.0)-甲醇(45∶55)为流动相,流速为1.0mL·min-1,柱温为30℃,检测波长为262nm。结果:马来酸氯苯那敏在0.100 4~4.016 0μg范围内与峰面积呈良好线性关系(r2=0.999 7),平均回收率为97.8%,RSD=1.6%(n=6);31批供试品有3批检测到非法添加的马来酸氯苯那敏。结论:该方法专属性强、灵敏度高,适用于测定抗过敏类健康产品中非法添加的马来酸氯苯那敏含量。
OBJECTIVE: To establish an HPLC method for the determination of chlorphenamine maleate illegally added in antiallergic health products. METHODS: Diamonsil C18 (4.6mm × 250mm, 5μm) was used as the mobile phase. The mobile phase consisted of 0.05mol / L potassium dihydrogen phosphate solution containing 1% triethylamine and 0.005mol / L sodium heptanesulfonate, 3.0) -methanol (45:55) as mobile phase at a flow rate of 1.0 mL · min-1. The column temperature was 30 ℃ and the detection wavelength was 262 nm. Results: Chlorphenamine maleate showed a good linear relationship with the peak area in the range of 0.100 4 ~ 4.016 0 μg (r2 = 0.999 7) with an average recovery of 97.8% and RSD of 1.6% (n = 6) Three batches of test products were tested for illegal addition of chlorpheniramine maleate. Conclusion: The method is highly specific and sensitive and suitable for the determination of chlorphenamine maleate illegally added to anti-allergic health products.