离子对高效液相色谱法测定美洛昔康含量及有关物质

摘　要：目的：为控制美洛昔康的含量和有关物质，建立了离子对高效液相色谱测定法。方法：色谱柱为Alltech公司AlltimaODS柱(250mm×4.6mm)，流动相：乙腈-含0.25%辛烷磺酸钠的0.1mol^.L^-1磷酸二氢钠(磷酸调至pH2.5)(65∶35)，流速：1mL^.min^-1，检测波长分别为355nm(含量测定)和271nm(有关物质测定)。结果：美洛昔康在9～110μg^.mL^-1范围内呈良好的线性关系，r＝0.9998。结论：本文改进的离子对高效液相色谱法为测定美洛昔康及其制剂的含量和有关物质提供了可靠基础。

关键词：离子对　高效液相色谱法　美洛昔康　有关物质

分类号：R927　文献标识码：A

Ion Pair HPLC Determination of Meloxicam and Its Related Substances

YU Hui（Zhejiang Institute for Drug Control,Hangzhou 310004）　
FANG Ying-zhi（Sir Run Run Shaw Hospital,Hangzhou 310016）　

Abstract：Objective：A HPLC method was established for the determination of meloxicam and its related substances.Methods:The separation was performed on a Alltech Alltima C₁₈ column (250 mm×4.6 mm).The mobile phase was composed of 0.25% sodium n-octyl sulfonate in acetonitrile-phosphate salt solution (65∶35).The detection was carried out with a dinode array detector at 355 nm and 271 nm respectively.Results:The calibration curves were linear between 9～110 μg^.mL^-1(r=0.999 8).Conclusion:This method is simple,rapid,accurate and is suitable for the determination of meloxicam and its related substances.

Keywords：ion pair,HPLC,meloxicam,related substance

参考文献：

［1］Noble S,Balfour J.Meloxicam.Drug,1996,51(3):424
［2］ChP(中国药典).2000.Vol Ⅱ(二部)：285(in Chinese)

收稿日期：2000年9月11日

出版日期：2001年3月31日