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建立了反相离子对色谱法测定口腔崩解片剂中溴吡斯的明血浆浓度的方法。血浆样品经液-液萃取法处理,采用反相离子对色谱法分离,以溴新斯的明作为内标定量。实验结果显示溴吡斯的明和内标物洗脱时间分别为5.63min和9.76min,与血浆中内源性杂质良好分离。溴吡斯的明线性范围为0.02—2.00mg.L-1(n=7,r=0.9994);样品绝对回收率为82.0%—89.2%,相对回收率为98.0%—100.0%,日内和日间RSD分别为2.0%—4.1%和3.1%—6.7%;当S/N=3时,溴吡斯的明检出浓度可达0.005mg.L-1。本方法准确、灵敏,可满足血药浓度检测和研究药代动力学行为的需要。
A method was developed for the determination of plasma concentration of tribromide in oral disintegrating tablets by reversed-phase ion pair chromatography. Plasma samples were processed by liquid-liquid extraction, separated by reversed-phase ion chromatography, and neostigmine bromide was used as internal standard. The experimental results showed that the internal and external standard elution time of bromopyrazine were 5.63min and 9.76min respectively, which was well separated from the endogenous impurities in plasma. The linear range of bromomin was 0.02-2.00mg.L-1 (n = 7, r = 0.9994). The absolute recoveries of samples were 82.0% -89.2% with the relative recoveries of 98.0% -100.0% The RSD was 2.0% -4.1% and 3.1% -6.7% respectively. When S / N = 3, the concentration of pyridostigmine was up to 0.005mg.L-1. The method is accurate and sensitive, which can meet the need of detecting and studying the pharmacokinetics of plasma concentration.