利多卡因羟甲唑啉溶液的质量标准研究

Study on the quality standard of Lidocaine and Oxymetazoline Solution

目的：建立利多卡因羟甲唑啉溶液的质量标准。方法采用化学显色法和色谱法对利多卡因和羟甲唑啉进行鉴别，并用高效液相色谱法分别测定利多卡因和羟甲唑啉的含量。结果制剂为无色至微黄色液体，鉴别、检查项均符合2010年版《中国药典》中的相关规定；利多卡因和羟甲唑啉分别在4．006～20．03μg （ r＝0．9994）和0．1004～0．5002μg （ r＝0．9990）范围内线性关系良好，二者的平均回收率分别为100．4％（RSD＝1．0％）和99．2％（RSD＝1．2％）。结论所建立的标准可用于该制剂的质量控制。

Objective To establish Lidocaine and Oxymetazoline Solution quality control method .Methods Colorimetric and chrom-atographic methods were used for identification of lidocaine and oxymetazoline .Meanwhile ,the main component in Lidocaine and Oxymetazoline Solution were determined by HPLC .Results The prepared solution was colorless to pale yellow liquid .The identi-fication and limit tests were all up to the standards specified in Chinese Pharmacopoeia （the 2010 edition） .The linear ranges of li-docaine and oxymetazoline （theophylline） were 4 .006-20 .03 μg （r=0 .999 4） and 0 .100 4-0 .500 2 μg （r=0 .999 0） ,respective-ly ,with the average recoveries 100 .4% （RSD= 1 .0% ） and 99 .2% （RSD= 1 .2% ） ,respectively .Conclusion The established quality control method could be used for the quality control .