高效液相色谱法测定复方阿司达莫人体血药浓度

目的：建立高效液相色谱法测定复方阿司达莫人体血药浓度。方法双嘧达莫色谱条件采用ODS C18（4．6mm×215;250mm ，5μm ）色谱柱；流动相甲醇-1％醋酸（25：75）；流速1．0 mL·min^-1；柱温30℃；检测波长285nm。水杨酸色谱条件ODS C18（3．9mm×150mm ，5μm）色谱柱；流动相为甲醇-1％醋酸（33：67）；柱温30℃；流速为1．0mL·min^-1；检测波长234nm。结果在0．05～8μg·mL^-1范围内，双嘧达莫最低定量限为0．05μg·mL^-1，线性关系良好（r＝0．9998，n＝6），方法回收率80．14％～104．78％，低、中、高三种浓度质控样品的日内、日间变异小于2．5％；在0．1～8μg＆#183;mL -1范围内，水杨酸最低定量限为0．1μg·mL^-1，线性关系良好（r＝0．9999，n＝6），方法回收率95．19％～100．06％，低、中、高三种浓度质控样品的日内、日间变异小于2．5％。结论该方法定量准确，灵敏度高，适用于复方阿司达莫人体药代动力学研究。

DETERMINATION OF COMPOUND DIPYRIDAMOLE AND SALICYLIC ACID BY HPLC

Objective To establish a method with high performance liquid chromatography （HPLC） for the determination of dipyridamole in human plasma .Methods The dipyridamole chromatographic condition included the ODS C18 column（4 .6×250m ,5μm） ,the chromatographic column of 30℃ ,the detection wave length of 285nm ,the mobile phase of methanol/-1% of acetic acid（25/75）and the flow rate of 1 .0 mL·min^-1 .The salicylic acid chromatographic condition included the ODS C18 column（3 .9 ×150mm ,5μm） , the chromatographic column of 30℃ ,the detection wave length of 234nm ,the mobile phase of methanol/-1% of acetic acid（33/67）and the flow rate of 1 .0 mL·min^-1 .Results A good linearity was obtained in the range of 0 .05-8μg · mL^-1 （r=0 .9998 ,n=6）with the minimum limit of dipyridamole being 0 .05μg ·mL^-1 and the recovery rate being within 80 .14%-104 .78% .The sample variation of the low ,moderate and high concentration was less than 2 .5% within a day and through a few days .A good linearity was obtained in the range of 0 .1-8μg·mL^-1 （r=0 .9999 ,n=6 ）with the minimum limit of dipyridamole being 0 .1μg ·mL^-1 and the recovery rate being within 95 .19%-100 .06% . The sample variation of the low , moderate and high concentration was less than 2 .5% within a day and through a few days .Conclusion The method is sensitive and accurate and is suitable for human pharmacoki-netic study on compound dipyridamole and salicylic acid.