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目的:建立头孢克肟缓释片体内血清浓度的HPLC测定方法,并对其口服制剂Beagle犬生物等效性进行研究。方法:以乙腈-0.01 mol.L-1磷酸二氢钾溶液(pH2.6)=(22∶78)为流动相,替硝唑为内标,流速1 mL.min-1,经Inertsil ODS-3色谱柱分离,检测波长为288 nm。结果:头孢克肟在0.5～40 mg.L-1(r=0.999 1)范围内,与峰面积呈良好的线性关系,平均相对和绝对回收率分别为103.5%和85.6%,平均日内和日间精密度分别为1.75%和2.25%。经统计学分析,头孢克肟缓释片和普通片的AUC0-t分别为(621.0±267.1)和(595.0±175.8)μg.h.L-1;AUC0-∞分别为(680.2±320.4)μg.h.L-1和(613.8±174.9)μg.h.L-1,相对生物利用度为:F0-t99.5%,置信区间为86.6%～114.3%。结论:本文所建立的反相高效液相色谱方法测定头孢克肟制剂在体内代谢的血清浓度,简便、快速、准确,适用于血清样品中头孢克肟浓度的定量分析测定。头孢克肟缓释片和普通片具有生物等效性。
OBJECTIVE: To establish a method for the determination of serum concentration of cefixime sustained-release tablets in vivo and to study the bioequivalence of its oral preparation Beagle dogs. Methods: The mobile phase was acetonitrile-0.01 mol·L-1 potassium dihydrogen phosphate solution (pH2.6) = (22:78), tinidazole was used as the internal standard and the flow rate was 1 mL.min-1. 3 column separation, detection wavelength of 288 nm. RESULTS: Cefixime showed a good linear relationship with the peak area in the range of 0.5-40 mg.L-1 (r = 0.999 1) with the average relative and absolute recoveries of 103.5% and 85.6%, respectively. The mean daily and daily Between the precision of 1.75% and 2.25%. The statistical analysis showed that the AUC0-t of cefixime sustained-release tablets and ordinary tablets were (621.0 ± 267.1) and (595.0 ± 175.8) μg.hL-1, respectively; the AUC0-∞ were (680.2 ± 320.4) -1 and (613.8 ± 174.9) μg.hL-1, the relative bioavailability was: F0-t99.5%, confidence interval of 86.6% to 114.3%. Conclusion: The established RP-HPLC method for the determination of serum concentration of cefixime metabolite in vivo is simple, rapid and accurate and suitable for the quantitative analysis of cefixime concentrations in serum samples. Cefixime sustained-release tablets and tablets are bioequivalent.