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目的建立准确测定清开灵注射液中氨基酸含量的方法。方法采用异硫氰酸苯酯为衍生化试剂,清开灵注射液衍生化反应后,进行HPLC分析。色谱柱为Diamonsil C18色谱柱(4.6 mm×250 mm,5μm);流动相A为0.1 mol/L醋酸钠-乙腈(pH 6.5)(93∶7),流动相B为乙腈-水(4∶1),梯度洗脱,流速为1 mL/min;检测波长为254 nm。结果该方法可以对清开灵注射液中20种氨基酸准确定量,其浓度在0.019～24.855 g/L范围内,线性关系良好(r=0.999 7～0.999 9)。方法重复性的RSD(%)在0.766%～4.49%之间;20种氨基酸的加样回收率在92.2%～106.8%之间。结论该方法准确、可靠、灵敏,可用于清开灵注射液中氨基酸的含量测定。
Objective To establish an accurate method for determination of amino acids in Qingkailing Injection. Methods Phenylisothiocyanate was used as derivatization reagent. After derivatization of Qingkailing injection, the HPLC analysis was carried out. The mobile phase A was 0.1 mol / L sodium acetate-acetonitrile (pH 6.5) (93: 7) and the mobile phase B was acetonitrile-water (4: 1 ), Gradient elution with a flow rate of 1 mL / min and a detection wavelength of 254 nm. Results The method could accurately quantify 20 kinds of amino acids in Qingkailing Injection and its concentration was in the range of 0.019-24.855 g / L with a good linear relationship (r = 0.999 7-0.9999 9). The repeatability RSD (%) was between 0.766% and 4.49%. The recoveries of 20 amino acids ranged from 92.2% to 106.8%. Conclusion The method is accurate, reliable and sensitive and can be used for the determination of amino acids in Qingkailing Injection.