高效液相色谱法测定高三尖杉酯碱氯化钠注射液含量及其有关物质的限量

Determination of homoharringtonine and sodium chloride injection and its related substance by HPLC

目的 :建立新的高效液相色谱法 (HPLC)分离测定高三尖杉酯碱及其降解产物。方法 :采用HPLC ,AgilentExtend C1 8色谱柱 ;甲醇 pH2 .5的磷酸盐缓冲液 三乙胺 (40∶60∶0 .1 )为流动相 ;流速为 0 .5ml·min- 1 ,检测波长 :2 4 0nm。结果 :在 1 .0 4～52 .2 0 μg·ml- 1 范围内 ,溶液的浓度与峰面积呈良好的线性关系。r =0 .9999,平均回收率 99.5 % (n =6) ,RSD =1 .0 % ,高三尖杉酯碱及其降解产物得到基线分离。结论 :本方法简便、快速、准确、灵敏 。

OBJECTIVE To establish an HPLC method for the determination of homoharringtonine injection and its related substance by HPLC.METHODS In HPLC analysis, the content of homoharringtonine was assayed on an agilent extend C 18 column with a mobile phase composed of methanol phosphate buffer solution (pH 2.5 ) triethylamine(40∶60∶ 0.1 ) at a flow rate of 0.5 ml·min -1 . The determination wavelength was 240 nm.RESULTS A good linearity was obtained of 1.04 ～ 52.20 μg·ml -1 . The average recovery of homoharringtonine was 99.5% ( n =6),RSD= 1.0% .CONCLUSIONS This method is simple, rapid, accurate and can be used to assay homoharringtonine and its degradation products.