高效液相色谱法测定复方美沙芬胶囊中美沙芬与布洛芬含量

THE ASSAY OF DEXTROMETHORPHAN HYDROBROMIDE AND IBUPROFENUM IN COMPOUND PREPARATION BY HPLC

目的：建立复方美沙芬胶囊中美沙芬与布洛芬的高效液相色谱测定法。方法：固定相Ｓｈｉｍｐａｃｋ ＣＬＣ－ ＯＤＳ柱，流动相乙腈－ 水（６５∶３５，含０．００７ｍｏｌ·Ｌ－１ 硝酸铵、０．００７ｍｏｌ·Ｌ－ １ ＳＤＳ，用冰醋酸调ｐＨ至３．４），流速１．０ｍｌ·ｍｉｎ－１，在２７０ｎｍ 处测定。结果：美沙芬含量线性范围０ ．０２ ～０．１０ｍｇ·ｍｌ－１ ，回归方程：Ｙ＝２．５１×１０３ ＋１．８４×１０６Ｘ，ｒ ＝０．９９９６ ；布洛芬含量线性范围０ ．２０～１．００ｍｇ·ｍｌ－１ ，Ｙ＝ １．８６×１０３＋ ５．１６×１０５Ｘ，ｒ ＝０．９９９７ 。结论：含量测定方法简便快速，结果准确，可用于该制剂的质量控制。

AIM To develop a method for the assay of the content of dextromethorphan hydrobromide and ibuprofenum in compound preparation by HPLC.METHODS The contents of dextromethorphan hydrobromide and ibuprofenum were detected at the wavelenth of 270nm with chromatography condition of shim-pack CLC-ODS,acetontitrile-water mobile phase and the velocity of 1ml·min -1 .RESULTS The linear ranges of dextromethorphan hydrobromide were both 0.02～0.10mg·ml -1 ,and regression equation was Y=-2.51×10 3+1.84×10 6X (r=0.9996) and Y=-1.86×10 3+5.16×10 5X(r=0.9997),respectively.CONCLUSION The analytical method was simple,quick and precise.