美洛昔康血药浓度的HPLC测定及其分散片的相对生物利用度

Determination of Meloxicam in Human Plasma by HPLC and Relative Bioavailability of Meloxicam Dispersible Tablets

建立了人血浆中美洛昔康的 HPL C测定法 ,以测定其分散片的相对生物利用度。血样经盐酸酸化后以乙醚提取 ,进行 HPL C分析 ,色谱柱为 Hypersil ODS2 (2 5 0× 4.6 m m,5 μm) ,流动相为甲醇 -水 -三乙胺 -冰醋酸 (2 5 0 0∶15 0 0∶ 15∶ 7)检测波长为 35 5 nm,尼美舒利为内标。结果表明在 0 .0 3～ 8.0 μg/ ml范围内峰面积与浓度线性关系良好 (r=0 .9999) ,最低检出浓度为 2 .5 ng/ ml,回收率为 93.6 %～ 97.7%。 2 0名健康受试者随机交叉口服国产和进口美洛昔康分散片后 ,其体内过程符合一室模型 。

A HPLC method was established for the determination of meloxicam in human plasma with nimesulide as the internal standard and was used to study the pharmacokinetics of meloxicam dispersible tablets. After acidify with hydrochloric acid, the plasma was extracted with ethyl ether and then analyzed by Hypersil ODS2 (250×4.6 mm,5 μm) column with the mobile phase of methanol-water-triethylamine-acetic acid(2500∶1500∶15∶7), and at the detection wavelength of 355 nm. Meloxicam was linear in the range of 0.03~8.0 μg/ml. The limit detection concentration was 2.5 ng/ml and the recovery was 93.6%~97.7%. The results of pharmacokinetics study after oral administration of domestic and imported preparations showed that the two formulations conformed to one compartment model and they were bio-equivalent.