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目的:建立人血清中苯酰甲硝唑体内代谢产物--甲硝唑的反相高效液相色谱分析方法,比较苯酰甲硝唑分散片和苯酰甲硝唑胶囊生物等效性。方法:采用Eurosphex-100 C18柱,以乙腈-KH2PO4(0．01 mol·L-1)(22:78,v／v)为流动相,替硝唑作内标,紫外检测波长为318 nm,测定血清中甲硝唑的血药浓度。结果:血清中甲硝唑的浓度在0．1-20．0μg·ml-1范围内线性关系良好,r=0．999 9(n=8)。受试制剂及参比制剂的Cmax分别为(10．475±2．135)和(10．118±2．116),Tmax分别为(4．000±1．414)和(4．667±1．138)h,t1／2分别为(11．247±2．264)和(10．800±2．000)h,根据AUC0→t计算受试制剂的相对生物利用度为(100．9±20．2)％。结论:本方法操作简便、灵敏度高、重现性好,可用于血清中甲硝唑浓度的测定。苯酰甲硝唑分散片和苯酰甲硝唑胶囊具有生物等效性。
OBJECTIVE: To establish a method for the determination of metronidazole in human serum by reversed-phase high performance liquid chromatography (HPLC), and to compare the bioequivalence of metronidazole metronidazole dispersible tablets and metronidazole metronidazole capsules. Methods: Tinidazole was used as internal standard with Europhex-100 C18 column and acetonitrile-KH2PO4 (0.01 mol·L-1) (22:78, v / v) Determination of serum metronidazole plasma concentration. Results: The concentration of metronidazole in serum was linear in the range of 0.1-20.0 μg · ml-1, r = 0.999 9 (n = 8). The Cmax of the test preparation and the reference preparation were (10.475 ± 2.135) and (10.118 ± 2.116), respectively, and the Tmax were (4.000 ± 1.414) and (4.667 ± 1 .138) h and t1 / 2 were (11.247 ± 2.264) and (10.800 ± 2.000) h, respectively. The relative bioavailability of the test preparation was calculated according to AUC0 → t (100.9 ± 20.2)%. Conclusion: The method is simple, sensitive, reproducible and can be used for the determination of metronidazole in serum. Benzyl metronidazole dispersible tablets and benzoyl metronidazole capsules have bioequivalence.