氨酚氢可酮口服溶液中4种成分的HPLC测定

HPLC determination of four components in hydrocodone bitartrate and acetaminophen oral solution

目的:建立 HPLC 法同时测定氨酚氢可酮口服溶液中主成分(对乙酰氨基酚、重酒石酸氢可酮)和防腐剂(对羟基苯甲酸甲酯、对羟基苯甲酸丙酯)的含量。方法:采用 Zorbax SB-C_(18)柱(4.6 mm×250 mm,5 μm);以0.025 mol·L^(-1)乙酸胺溶液(用冰醋酸调 pH 至4.0)-乙腈(19:81)为流动相 A,0.025 mol·L^(-1)乙酸胺溶液(用冰醋酸调 pH 至4.0)-乙腈(75:25)为流动相 B 进行梯度洗脱;流速为1.0 mL·min^(-1);柱温为35℃;检测波长为280 nm(对乙酰氨基酚)、214 nm(重酒石酸氢可酮)和257 nm(对羟基苯甲酸甲酯和对羟基苯甲酸丙酯)。结果:对乙酰氨基酚、重酒石酸氢可酮、对羟基苯甲酸甲酯和对羟基苯甲酸丙酯的线性范围分别为133.4～1668,2.272～28.40,7.278～90.97,0.7960～9.950μg·mL^(-1);加样回收率(n=9)分别为98.6%,103.7%,100.2%,103.5%。结论:方法简便、准确,可用于氨酚氢可酮口服溶液中4种成分的同时测定。

Objective：To establish the HPLC method to determine simultaneously the contents of four components such as hydrocodone bitartrate, acetaminophen, methyl p - hydroxybenzoate and propyl p - hydroxybenzoate in hydrocodone bitartrate and acetaminophen oral solution, Methods：The four components were separated on Zorbax SB- C18 column（4. 6 mm 250 mm,5 μm） by gradient elution using 0. 025 mol ·L^-1 ammonium acetate（ adjusted to pH 4, 0 with acetic acid glacial） -acetonitrile. The detection wavelength：280 nm （acetaminophen）,214 nm （ hydrocodone bitartrate） and 257 nm （ methyl p - hydroxybenzoate and propyl p - hydroxybenzoate）. The flow rate was 1.0 mL · min^-1. The column temperature was 35 ℃. Results：The linear range of hydrocodone bitartrate, acet- aminophen, methyl p -hydroxybenzoate and propyl p - hydroxybenzoate were 133.4 - 1668,2. 272 -28.40,7. 278 -90. 97 and 0. 7960 -9. 950 μg · mL^-1 ,respectively. The average recoveries were 98.6% ,103.7% ,100.2% and 103.5%,respectively. Conclusion：The method is simple and accurate, and can be used to determine the contents of four components in hydrocodone bitartrate and acetaminophen oral solution.