克拉霉素血药浓度HPLC 测定方法和生物等效性研究

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(4.6 mm ×150 mm),流动相为乙腈:0.02 mol·L^-1KH₂PO₄ (pH=3.07)=32∶68,流速为1.0 ml·min^-1,检测波长为210 nm 。结果: 本方法在0.05 ~ 3.2mg·L^-1浓度范围内线性关系良好。最低可定量浓度为0.05mg·L^-1(信噪比>3),两制剂间AUC、Cmax、T_max、t_12β药动学参数经统计学检验无显著性差异(P>0.05)。供试制剂的相对生物利用度为(101.10 ±19.40)%。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。

Determination of clarithromycin in human plasma by HPLC method and study of clarithromycin bioequivalence

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 C18 (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_maxand t_12β 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.