摘要
目的采用HPLC法测定犬血浆中雷诺嗪缓释片的浓度。方法用乙腈沉淀蛋白,离心后取上清液用氮气吹干,流动相溶解后进行HPLC测定。采用DiamonsilTM C18色谱柱(250mm×4.6mm,5μm)、资生堂MG C18色谱柱(150mm×4.6mm,5μm),流动相为乙腈-水相(7mmol·L-1乙酸铵、3.5mmol·L-1乙酸、1‰三乙胺)(50:50);检测波长230nm;流速0.8mL·min-1;柱温30℃;进样量40μL。犬灌胃给药雷诺嗪缓释片剂量为25mg·kg-1,于不同时间取血,依法测定。结果雷诺嗪的线性范围为0.1～20μg·mL-1(r=0.9998,n=5),高、中、低浓度的日内、日间RSD均小于15%,方法回收率为88%～105%。缓释片和普通片的Cmax分别为1.59±1.07、3.48±2.11μg·mL-1。结论所建方法简便、准确,适用于犬血浆中雷诺嗪的测定及雷诺嗪缓释片的人体药物动力学、生物利用度和生物等效性的研究。雷诺嗪普通片口服吸收快、吸收良好,缓释片无突释现象,具明显缓释作用。
OBJECTIVE To establish an HPLC method for the determination of Ranolazine concentration in dog plasma.METHODS Plasma protein was precipitated by the addition of acetonitrile.The resulting supernatant liquid was dried by nitrogen and was analyzed by the HPLC method after it was diluted quantitatively by mobile phase.C18 column was used.The mobile phase consisted of acetonitrile-water（7 mmol·L^-1 ammonium acetate,3.5 mmol·L^-1 acetic acid and 1‰ triethylamine）（50：50） at flow rate of 0.8 mL·min^-1 and the detective wavelength was 230 nm.RESULTS A good linearity was shown in the range of 0.1-20 μg·mL^-1（r = 0.9998,n = 5）.The intra-day RSD and inter-day RSD were less than 15%.The recovery was within 88%-105%.CONCLUSION This method is simple,accurate and applicable to study on pharmacokinetics,bioavailability and bioequiavailability of Ranolazine.
出处
《华西药学杂志》
CAS
CSCD
北大核心
2010年第4期456-458,共3页
West China Journal of Pharmaceutical Sciences
