HPLC法测定复方对乙酰氨基酚片中对氨基酚和对氯苯乙酰胺的含量  

Determination of P-aminophenol and P-chloroacetanilide in Compound Paracetamol Tablets by HPLC

作　　者：王英瑛 李俊 杨玉琴 Wang Yingying;Li Jun;Yang Yuqin(Zhejiang Taizhou Institute for Food and Drug Control, Zhejiang Taizhou 318000, China)

机构地区：[1]台州市食品药品检验研究院,浙江台州318000

出　　处：《中国药师》2018年第7期1303-1305,共3页China Pharmacist

摘　　要：目的:建立HPLC法测定复方对乙酰氨基酚片中对氨基酚和对氯苯乙酰胺的含量。方法:采用CAPCell PAK C_8柱(250 mm×4.6 mm,5μm);流动相为磷酸盐缓冲液(取磷酸氢二钠8.95 g,磷酸二氢钠3.9 g,加水溶解至1 000 ml,加10%四丁基氢氧化铵溶液12 ml)-甲醇(70∶30);柱温:35℃;流速:1.5 ml·min^(-1);检测波长:245 nm;进样量:20μl。结果:对氨基酚和对氯苯乙酰胺与各主成分及相邻的杂质均能够很好的分离,对氨基酚和对氯苯乙酰胺分别在4.02~20.12μg·ml^(-1)(r=1.000 0)和0.20~1.01μg·ml^(-1)(r=0.999 9)的范围内线性关系良好,平均回收率分别为95.7%,99.6%,RSD分别为2.6%,8.7%(n=9),最低检出限分别为0.02,0.03μg·ml^(-1)。结论:该方法简便快速,结果准确,可用于复方对乙酰氨基酚片的质量控制。Objective： To establish an HPLC method for the determination of p-aminophenol and p-chloroacetanilide in compound paracetamol tablets. Methods： The HPLC separation was performed on a CAPCell PAK C8 column（ 250 mm × 4. 6 mm,5 μm） with the mobile phase consisting of phosphate buffer（ 8. 95 g disodium hydrogen phosphate and 3. 9 g sodium dihydrogen phosphate were dissolved in water to obtain 1 000 ml solution,and then added 12 ml 10% solution of tetrabutylammonium hydroxide）-methanol（ 70 ∶30） at a flow rate of 1. 5 ml·min^-1. The column temperature was 35℃ and the detection wavelength was 245 nm. Results： P-aminophenol and p-chloroacetanilide could well separate from the principal components and the adjacent impurities P-aminophenol and pchloroacetanilide revealed good linearity within the range of 4. 02-20. 12 μg · ml^-1（ r = 1. 000 0） and 0. 20-1. 01 μg·ml^-1（ r =0. 999 9）,and the average recovery was 95. 7% and 99. 6% with the RSD of 2. 6% and 8. 7%（ n = 9）,respectively. Conclusion：The method is convenient,fast and accurate,and can be used for the quality control of compound paracetamol tablets.

关 键 词：高效液相色谱法 复方对乙酰氨基酚片 对氨基酚 对氯苯乙酰胺 

分 类 号：R927.2[医药卫生—药学]