用高效液相色谱法测定血清中尼群地平的浓度

Determination of serum nitrendipine concentration by HPLC-UV

目的：建立测定血清中尼群地平浓度的高灵敏度高效液相色谱方法，用于尼群地平临床药物代谢动力学的研究和临床治疗检测。方法：以尼群地平为内标，使用紫外检测器，血清标本经有机溶剂提取后，上层有机相在空气流下吹干，重组后进行色谱分析。结果；在该方法条件下，浓度为150，50和15ny/ml的尼群地平的平均回收率分别为86.2％，88.2％和87．3％（n=8），平均日内不精密度分别为3．7％，3．1％和5．2％（n=8），平均日间不精密度分别为5．1％，4．7％和7．8％（n=10）。方法的最低检出浓度为6．5ng／ml。结论：方法选择性好，灵敏度高，可测出临床药物代谢动力学研究和临床治疗检测中较低浓度的标本。

Objective To set up a high sensitive HPLC method for determination of nitrendipine in serum fromclinical pharmacokenetic study and therapy monitoring. Methods To use Waters HPLC-UV system and nimodip-ine as the internal standard. Samples were extracted by tert -butylmethylene /n-hexane (1: 1 ). The upper layerorganic phase was transferred into a clean tube and evaporated under a gentle stream of air at 50℃. The residuewas reconstitutcd in 100 ul of mobile phase and a 50 ul aliquot was injected into the HPLC system. Rcsults Ni-trendipine and nimodipine were separated at base line. The calibration graph was linear over the range 6. 5~ 150ng/ml. The inter-assayrelative standard deviations(R. S. D) at 150, 50, 15 ng/ml were 3. 7%, 3. 1 %,and 5. 2 %,respectively(n = 8). The intra-assay R>S>D at150, 50, 15 ng/ml were 5. 1 %, 4. 7 %,and7. 8%,respectively (n =10). Conclusion our method is highly sensitive for nitrendipine assay and has been used for pharmacokeneticstudying in our laboratory.