RP-HPLC测定人血浆中盐酸依匹斯汀浓度及其药动学

Determination of epinastine hydrochloride in human plasma by RP-HPLC

目的建立RP-HPLC测定人血浆中盐酸依匹斯汀浓度。方法采用Agilent 1100系列高效液相色谱仪。色谱柱Kro—masilTMC18(4.6 mm×150 mm,7μm);固定进样环50 μL;流动相为乙腈-磷酸盐缓冲液(0.05 mol·L-1KH2PO4用H3PO4调pH至3.5)(30:70),流速1.0 mL·min-1;紫外检测波长:210 nm;柱温:室温;内标为替硝唑。结果盐酸依匹斯汀血药浓度线性范围为1.062 5-34.000 0 ng·mL-1,最低检测浓度1.062 5 ng·mL-1;方法回收率为94.02%-106.46%;日内、日间RSD分别为2.54%-8.09%和4.90%-9.09% 结论本法灵敏、准确,可用于盐酸依匹斯汀进一步的临床研究。

OBJECTIVE: To establish a RP-HPLC method for the determination of epinastine hydrochloride in human plasma. METHODS: The drug and internal standard (tinidazole, TDZ) were extracted from plasma with dichloromethane. The compounds were separated on a HYPERSIL C18 column (4.6 mm × 150 mm, 7 μm) by Agilent 1100 HPLC. The mobile phase was a mixture of acetonitrile-0.05 mol&middotL-1KH2PO4 with a ratio of 30:70 (adjusted pH to 3.5 by H3PO4). The detection wavelength was 210 nm. RESULTS: A good linearity was obtained over the range of 1.062 5 to 34.000 O ng&middotmL-1 in plasma. The limit of detection was 1.062 5 ng&middotmL-1. The recoverys of method were from 94.02% to 106.46%. The precisions of intra-day and inter-day were 2.54% ∼ 8.09% and 4.90% ∼ 9.09%, respectively. CONCLUSION: The method is sensitive, accurate and reliable, and can be used in clinical research of epinastine hydrochloride.