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目的采用反相高效液相色谱法测定福多司坦胶囊的光学纯度。方法采用DiamonsilTM(钻石)C18色谱柱(250mm×4.6mm,5mm),流动相:硫酸铜D-苯丙氨酸溶液-甲醇(100∶10),流速为0.8mLomin-1,检测波长270nm,柱温35℃,进样量为20μl。结果福多司坦与光学异构体之间的分离度为4.0,最低检出量约为16.7ng(S/N=3.0),方法专属性强,灵敏度高。结论此反相HPLC法可用于福多司坦胶囊的光学纯度检查。
OBJECTIVE To determine the optical purity of furadatang capsules by reversed-phase high performance liquid chromatography. Methods DiamonsilTM (diamond) C18 column (250mm × 4.6mm, 5mm) was used. The mobile phase consisted of copper sulfate D-phenylalanine solution (100:10), flow rate of 0.8mLomin-1, detection wavelength of 270nm, Temperature 35 ℃, injection volume of 20μl. Results The separation between fudosteine and optical isomers was 4.0 and the minimum detectable volume was about 16.7ng (S / N = 3.0). The method was specific and sensitive. Conclusion This reversed-phase HPLC method can be used for the optical purity of furadatang capsules.