RP-HPLC法测定复方氨酚氢可酮片中的有关物质对氨基酚  

Determination of 4-aminophenol in hydrocodone bitartrate and acetaminophen tablets by RP-HPLC

作　　者：肖宇[1] 邓盛齐[1] 丁始安[1] 李楠[1] 

机构地区：[1]成都大学四川抗菌素工业研究所,成都610052

出　　处：《药物分析杂志》2014年第12期2198-2201,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的：建立复方氨酚氢可酮片中的有关物质对氨基酚的测定方法。方法：采用依利特Hypersil BDS C8色谱柱（4.6 mm×250 mm,5μm）,以磷酸盐缓冲液-甲醇为流动相,进行梯度洗脱,流速1 m L·min^-1,检测波长245 nm。结果：依本法进行测定,片剂中其他成分及杂质不干扰对氨基酚的测定,对照品溶液浓度在0.21-52.45μg·m L^-1范围内线性关系良好（r=0.9999,n=7）;定量限与检测限分别为0.84、0.17 ng;重复性试验中RSD（n=6）为4.4%;回收率在99.1%-101.2%之间。结论：本法经方法学验证可用于复方氨酚氢可酮片中有关物质对氨基酚的检查。Objective： To establish a method for determination of the related substance 4 - aminophenol in hydroc- odone bitartrate and acetaminophen tablets. Methods： An Elite Hypersil BDS C8 column （4. 6 mm× 250 mm,5 μm） was adopted with a mixture of phosphate buffer and methanol as the mobile phase at the flow rate of 1 mL · min^-1 in the form of gradient elution. The detection wavelength was set at 245 nm. Results： 4 - aminophenol was completely separated from other substances and impurities in hydrocodone bitartrate and acetaminophen tablets with no interference by using this method. The calibration curve was in good linearity （ r = 0. 9999, n = 7 ） within the range of 0. 21 -52.45 μg · mL^-1 for 4 - aminophenol, the LOQ was 0. 84 ng and the LOD was 0. 17 ng, the RSD for repeatability was 4.4%. The recovery was within 99. 1% - 101.2%. Conclusion： The method is in accordance with requirements of methodology validation and reliable for determination of 4 - aminophenol in hydrocodone bitartrate and aeetaminophen tablets.

关 键 词：复方氨酚氢可酮片 对乙酰氨基酚 杂质检测 对氨基酚 反相高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]