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目的建立测定Beagle犬血浆中雷诺嗪浓度的高效液相色谱-紫外检测方法。方法血浆样品中加入内标苯海拉明,经氢氧化钠溶液碱化后用乙醚提取。色谱柱为Diamonsil C_(18)(250mm×4.6mm,5μm),流动相为甲醇-含醋酸胺50mmol·L~(-1)水溶液(58:42,V/V),柱温为50℃,流速为1.0 mL·min~(-1),测定波长为270nm。采用BAPP2.0程序计算雷诺嗪普通片和缓释片的药动学参数。结果雷诺嗪在0.04～2.56mg·L~(-1)范围内线性关系良好,定量下限为0.04mg·L~(-1),提取回收率为92%～97%,批内、批间RSD均小于10%。雷诺嗪缓释片的相对生物利用度为(102±14)%。结论本方法操作简便、准确、重现性好,符合生物样品的分析要求,可以用于雷诺嗪的生物利用度研究。
Objective To establish a HPLC method for the determination of ranolazine in plasma of Beagle dogs. Methods The internal standard diphenhydramine was added to the plasma samples, basified by sodium hydroxide solution and extracted with ether. The column was Diamonsil C 18 (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of 50 mmol·L -1 aqueous solution of acetic acid and acetic acid (58:42 V / V) The flow rate was 1.0 mL · min ~ (-1) and the measurement wavelength was 270 nm. BAPP2.0 program was used to calculate the pharmacokinetic parameters of ranolazine tablets and sustained-release tablets. Results Ranolazine showed a good linearity in the range of 0.04-2.56 mg · L -1 with a lower limit of quantification of 0.04 mg · L -1 and a recovery of 92% -97%. The intra-and inter-assay RSD Less than 10%. The relative bioavailability of ranolazine sustained-release tablets was (102 ± 14)%. Conclusion The method is simple, accurate, reproducible and meets the analytical requirements of biological samples. It can be used to study the bioavailability of ranolazine.