HPLC-MS同时测定人血浆中阿莫西林和克拉维酸的浓度

Determination of Amoxicillin and Clavulnanic Acid in Human Plasma by HPLC-MS

目的 :同时测定人血浆中阿莫西林及克拉维酸的浓度 ,并用本法研究 Augmentin(阿莫西林∶克拉维酸钾 =7∶ 1 )干混悬剂的人体相对生物利用度。方法 :色谱柱为 Kromasil ODS 1 5 0 mm× 4 .6 mm ID,5μm,检测器为四极质谱检测器。内标为头孢羟氨苄 ,血浆样品通过 Microcon YM-1 0超滤膜超滤制备。结果 :阿莫西林、克拉维酸的线性范围分别为 0 .0 4～ 4 0 μg/ ml和 0 .0 2～ 2 μg/ ml,方法的回收率大于 80 %。 2 0名志愿者随机交叉口服单剂量 Augmentin的干混悬剂和分散片后 ,以本法测定其体内血药浓度经时过程。两种制剂的 AUC0→ 8,Cmax,Tmax均无显著性差异。结论 :阿莫西林和克拉维酸血药浓度的同时测定结果表明两种制剂生物等效 ,干混悬剂对分散片两成分的相对生物利用度分别为 1 0 1 .7%和 99.2 %。

AIM The purpose is to establish HPLC-MS method for the determination of amoxicillin and clavulnanic acid in human plasma. METHODS Ultrafiltration was uesd to remove protein from plasma. Amoxicillin and clavulnanic acid were determinationed by HPLC-MS(column: Kromasil-ODS, 5 μm,150×4.6 mm ID). RESULTS Good linearity were obtained from 0.04 μg·ml -1 to 40 μg·ml -1 of amoxicillin with a correlation coefficeint of 0.9997 and from 0.02 μg·ml -1 to 5 μg·ml -1 of clavulnanic acid with a correlation coefficeint of 0.9990 in human plasma. The recovery of method was more than 80%. CONCLUSION The established HPLC-MS method was found to be a good method for the determination of amoxicillin and clavulnanic acid in human plasma. The results of statistical analysis showed that the two preparations of augmentin(comprised of amoxicillin and clavulnanic acid) were biologically equivalent.