摘要
目的采用高效液相色谱法测定注射用赖氨匹林中阿司匹林含量并对其降解产物水杨酸进行控制。方法以十八烷基键合硅胶为填充剂,甲醇-0.1%三乙胺溶液(1:1,冰醋酸调节pH至3.5)为流动相,检测波长为280nm,以峰面积外标法计算。结果阿司匹林和水杨酸在60.34—905.10mg/L和1、20—18.00mg/L浓度范围内呈良好的线性关系,其线性相关系数分别为0.9999和0.9999;加样回收率分别为98.76%-99.29%(RSD=0.59%-0.93%)和98.49%-99.69%(RSD=0.80%-1.01%)。结论本法简便、快速,结果准确、可靠。
Objective To establish a HPLC method for determination of aspirin and for control of its related substance salicylic acid in lysinipirine for injection. Methods The colomm was Hypersil C18 (150μm×4.6μm,10μm).The mobile phase consisted of methane-0.1%triethylamine (1:1, use actic acid glacial pH3.5)with a detecting wavelength of 280nm and external standard method. Results The calibration curves had good linearity in the range of 60.34-905.10mg/L uspirin and 1.20-18.00mg/L salicylic acid,and the correlation coefficients were 0.9999 and 0.9999 for aspirin and salicylic aicd respectively.The average recoveries of aspirin and salicylic acid added were 98.97%-99.29%(RSD=0.59%-0.93%) and 98.49%-99.69%(RSD=0.80%-1.01%). Conclusion The method is simple, rapid and the result is accurateand reliable.