HPLC法测定氨金黄敏颗粒中对乙酰氨基酚和马来酸氯苯那敏的含量

Determination of Chlorpheniramine Maleate and Acetaminophen in Paracetamol,Anantadine Hydrochloride,Artificid Cow-bezar and Chlorphenamine Mdeate Granules by HPLC

目的建立HPLC法测定氨金黄敏颗粒中马来酸氯苯那敏和对乙酰氨基酚的含量。方法采用C18色谱柱(250 mm×4.6 mm,5μm),以甲醇-0.05 mol/L磷酸二氢钠溶液-三乙胺(10∶90∶0.02)(用磷酸调节pH至3.5)为流动相,柱温30℃,流速为1.0 mL/min,检测波长为210 nm,进样量为20μL。结果线性范围分别为马来酸氯苯那敏4.832～11.275μg/mL,r=0.999 8,对乙酰氨基酚362.08～844.86μg/mL,r=0.999 7;平均回收率为马来酸氯苯那敏99.0%(RSD=0.84%),对乙酰氨基酚101.8%(RSD=0.87%)。结论本文方法快速,准确,可作为本品质量评价和生产工艺监控的有效方法。

Objective To establish an HPLC method to determine chlorpheniramine maleate and acetaminophen in paracetamol, anantadine hydrochloride, artificid cow-bezar, and chlorphenamine mdeate granules. Methods A C18 column （250 mm ×4.6 mm,5μm） was used, the column temperature was set at 30℃, the mobile phase was consisted by methanol - 0. 05 mol/L sodium dihydrogen phosphate-triethylamine （ 10 ： 90 ： 0. 02 ） （ adjusted to pH3. 5 with phosphoric acid）, and flow rate was 1.0 mL,/min, the detection was conducted at wavelength of 215 nm. Results The calibration curves were linear in the range of 4. 832 ~ 11. 275 μg/mL （ r = 0.999 7 ） for chlorpheniramine maleate and 362.08 - 844.86μg/mL （ r = 0. 999 7 ） for acetaminophen. The average recovery of chlorpheniramine maleate was 99.0% with RSD of 0. 84%, and the average recovery of acetaminophen was 101. 8% with RSD of 0. 87%. Conclusion This proposed method appeared to be simple, rapid and accurate. It can be used to control the product quality and preparation process.