【摘要】 目的 :建立一种固相萃取的克拉霉素血药浓度HPLC测定方法 ,进行生物等效性分析。方法 :采用高效液相色谱法 ,色谱柱为C18柱 (4 .6mm×15 0mm) ,流动相为乙腈 :0 .0 2mol·L-1KH2 PO4(pH=3.0 7) =32 6 8,流速为 1.0ml·min-1,检测波长为 2 10nm。结果 :本方法在 0 .0 5～ 3.2mg·L-1浓度范围内线性关系良好。最低可定量浓度为0 .0 5mg·L-1(信噪比 >3) ,两制剂间AUC、Cmax、Tmax、t1 2 β药动学参数经统计学检验无显著性差异 (P >0 .0 5 )。供试制剂的相对生物利用度为 (10 1.10±19 .4 0 ) %。结论 :本HPLC方法简单、快速、准确 ,很好地评价了两种制剂的生物等效更多还原

【Abstract】 AIM: To establish a HPLC method to determine the concentration of clarithromycin in human plasma, and to study clarithromycin bioequivalence by this method. METHODS: A HPLC assay was developed. Chromatographic assay was performed on a column of diamonsil C 18( 4.6 mm×150 mm). The mobile phase was a mixture of acetonitrile and water (3268), the flow rate 1.0 ml·min -1, and the detection wavelength 210 nm. RESULTS: The calibration curve was linear in the range of 0.05- 3.2 mg·L -1. The minimum detection concentration was 0.05 mg·L -1. The values of AUC, C max, T max and t 1/2β of two preparations did not show significant difference (P> 0.05). The relative bioavailability was ( 101.10± 19.40)%. CONCLUSION: The proposed method can be applied to the assay of clarithromycin in reverse phase conditions easily and rapidly, and the two preparations of clarithromycin hydrochloride are bioequivalent.更多还原