高效液相色谱法测定对乙酰氨基酚的血药浓度及其生物利用度

HPLC determination of paracetamol in plasma and bioavailability assessment of paracetamol tablets

目的 :建立高效液相色谱 (HPLC)法测定对乙酰氨基酚血药浓度的方法并对其分散片的生物利用度进行研究。方法 :以HPLC外标法测定人血浆中对乙酰氨基酚的浓度 ,流动相为甲醇 /乙腈 /水 (5∶5∶90 ) ,紫外吸收波长为 2 37nm。 12名健康志愿者服药后 ,依据对乙酰氨基酚分散片和对照片经时血药浓度 ,研究了 2种制剂相对生物利用度。结果 :本法对血浆中药物的最低检测浓度为 0 1μg·mL-1,线性范围为 0 2～ 18 0 μg·mL-1,回收率 >90 % ,日内RSD为 0 71%～ 1 6 5 % ,日间RSD为0 77%～ 4 41%。按AUC0→∞ 计算出对乙酰氨基酚分散片的相对生物利用度为 (10 7 8± 14 3) %。结论 :本法简便快速 ,可用于临床血药浓度测定。 2种对乙酰氨基酚制剂具有生物等效性。

AIM:To establish a high performance liquid chromatography(HPLC) method for the determination of paracetamol in human plasma and for bioavailability assessment of 2 kinds paracetamol tablets. METHODS:The mobile phase was composed of methanol acetonitrile water (5∶5∶90). The UV detector wavelength was at λ=237 nm. The detection limit was 0.1 μg·mL -1 ,the calibration curve was linear in the range from 0.2 μg·mL -1 to 18.0 μg·mL -1 . The relative bioavailability of 2 kinds of tablets was studied according to the concentrations of paracetamol in human plasma via time. RESULTS: The recovery of paracetamol from human plasma was more than 90%, the RSD within day was 0.71%- 1.65%, the RSD between day was 0.77%-4.41%. The relative bioavailability of test tablets was (107.8±14.3)%. CONCLUSION: The HPLC method is sample and rapid,the 2 paracetamol tablets are bioequivalent.