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目的:建立测定人血浆中盐酸依匹斯汀浓度的HPLC方法。方法:采用Waters Symmetry shield C_(18)(150 mm×3.9 mm,5μm)色谱柱;以乙腈-0.3%三乙胺(磷酸调pH为3.5)(22:78)为流动相;流速为1.0 ml·min~(-1);紫外检测波长为220 nm。结果:线性范围为2~200μg·L~(-1);最低检测浓度为2μg·L~(-1);方法回收率为98.17%~102.19%;日内RSD 6.87%~10.81%;日间RSD 3.6%~4.4%。结论:本方法灵敏、准确,可用于人血浆中盐酸依匹斯汀的浓度测定。
Objective: To establish an HPLC method for the determination of the concentration of epinastine hydrochloride in human plasma. METHODS: The column was eluted with a Waters Symmetry shield C 18 (150 mm × 3.9 mm, 5 μm) column with acetonitrile-0.3% triethylamine (adjusted to pH 3.5 with phosphoric acid) (22:78) · Min ~ (-1); UV detection wavelength of 220 nm. Results: The linear range was 2 ~ 200μg · L -1; the lowest detection concentration was 2μg · L -1; the recoveries were 98.17% -102.19%; the intraday RSD was 6.87% -10.81%; the daytime RSD 3.6% ~ 4.4%. Conclusion: The method is sensitive and accurate and can be used to determine the concentration of epinastine hydrochloride in human plasma.