摘要
目的建立同时测定人血浆中对乙酰氨基酚、水杨酸和咖啡因浓度的HPLC法,并将其应用于阿咖酚胶囊复方制剂的人体药动学研究。方法以甲醇-四氢呋喃-10 mmol.L-1醋酸盐缓冲液(含体积分数为0.1%的冰醋酸溶液)(体积比为23∶2∶77)为流动相,茶碱为内标,采用krom asil苯基柱分离,在237 nm处进行检测。结果血浆中对乙酰氨基酚、水杨酸和咖啡因测定方法的线性分别为0.203~16.2、0.503~80.4、0.103~8.24μg.L-1;方法的准确度?RE?分别为-4.2%~0.5%、-9.2%^-0.5%、-7.8%~1.9%;日内精密度?RSD?分别小于5.2%、6.5%、7.0%;日间精密度?RSD?分别小于8.1%、5.2%、6.2%。结论建立的HPLC方法可用于阿咖酚胶囊复方制剂的人体药动学研究。
Objective To develop an HPLC method for simultaneous determination of paracetamol, salicylic acid and caffeine in human plasma and apply this method to the pharmacokinetic study of paracetamol, caffeine and aspirin capsules. Methods Theophylline was used as the internal standard. Plasma samples treated with ethyl acetate were separated on a phenyl column with a mobile phase of methanol-tetrahydrofuran 10 mmol·L^-1 ammonium acetate buffer containing 0.1% acetic acid ( V: V: V = 23: 2: 77 ) and detected at 237 nm. Results Calibration curve was linear in the range of 0. 203- 16. 200 g· mL^-1 for paracetamol,0. 503-80.400 g·mL^-1 for salicylic acid and 0. 103-8. 240 g·mL^-1 for caffeine. The accuracy(RE)of the method was -4. 2%-0. 5%, -9.2%- -0. 5% and -7.8%-1.9% for paracetamol,salicylic acid and caffeine,respecfively. The inter-and intra-day precisions were less than 8% ,6. 4% and 6. 9% for paracetamol, salicylic acid and caffeine, respectively. Conclusions This HPLC method is proved to be superior in speed of analysis in comparison to the method reported previously and suitable for pharmacokinetic study of paracetamol, caffeine and aspirin capsules.
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2009年第7期547-550,582,共5页
Journal of Shenyang Pharmaceutical University