| | | | | 氨酚氢可酮口服溶液中4种成分的HPLC测定 | | | 王慧;南楠;苏元华 | | | 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。
【作者单位】：中国药品生物制品检定所;中国药品生物制品检定所;北京紫竹医药经营有限公司 北京 100050;北京 100050;北京 100088
【关键词】：氨酚氢可酮口服溶液;对乙酰氨基酚;重酒石酸氢可酮;对羟基苯甲酸甲酯;对羟基苯甲酸丙酯;高效液相色谱法
【分类号】：R927
【DOI】：CNKI:SUN:YWFX.0.2007-06-021
【正文快照】：
氨酚氢可酮口服溶液是重酒石酸氢可酮和对乙酞氨基酚的复方制剂(由重酒石酸氢可酮0.509,对乙酞氨基酚33.339,防腐剂对经基苯甲酸甲醋1.8g和对经基苯甲酸丙醋0.29,辅料适量,加纯水至r000 mL配制而成),主要用于中重度疼痛的治疗,尤其是急性中重度疼痛,包括创伤及外科手术后疼痛、 | | |  推荐 CAJ下载  PDF下载 | | | CAJViewer7.0阅读器支持所有CNKI文件格式，AdobeReader仅支持PDF格式 | | | | HPLC determination of four components in hydrocodone bitartrate and acetaminophen oral solution | | | WANG Hui NAN Nan National Institute for the Control of Pharmaceutical and Biological Products;Beijing 100050;China;SU Yuan-hua Beijing Zizhu Pharmaceutical Business Co.Ltd.;Beijing 100088;China | | | 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-C_(18)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 hvdrocodone,bitartrate and acetaminophen oral solution.
【Keyword】：hydrocodone bitartrate and acetaminophen oral solution;acetaminophen;hydrocodone bitartrate;methyl p-hydroxybenzoate;propyl p-hydroxybenzoate;HPLC |
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