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目的建立柱前衍生化HPLC法测定依达拉奉注射液中L-半胱氨酸盐酸盐含量的方法。方法以异硫氰酸苯酯为柱前衍生化试剂,采用C18色谱柱,流动相为乙腈-0.1mol.L-1醋酸钠溶液(用冰醋液调节pH至6.5)(45∶55),流速为1.0mL·min-1,检测波长254nm。结果 L-半胱氨酸盐酸盐衍生物浓度在0.4～4.0μg·mL-1范围内与其峰面积呈良好的线性关系(r=0.9998);平均回收率100.5%,RSD为1.4%(n=9)。结论本方法快速准确。
OBJECTIVE To establish a method for the determination of L-cysteine hydrochloride in edaravone injection by precolumn derivatization. Methods Phenylisothiocyanate was used as a pre-column derivatization reagent. The mobile phase consisted of acetonitrile-0.1mol.L-1 sodium acetate solution (adjusted to pH6.5 with glacial acetic acid solution) by C18 column (45:55) The flow rate was 1.0 mL · min-1 and the detection wavelength was 254 nm. Results The linear range of the L-cysteine hydrochloride derivative concentration was 0.4-4.0 μg · mL-1 (r = 0.9998). The average recovery was 100.5% and the RSD was 1.4% (n = 9). Conclusion This method is fast and accurate.