高效液相色谱法测定人血浆中盐酸伪麻黄碱质量浓度

目的建立高效液相色谱法,用于测定人血浆中盐酸伪麻黄碱的质量浓度。方法采用内标法,以ODS柱（250 mm×4.6 mm,5μm）为固定相、60 mmol/L十二烷基硫酸钠、60 mol/L磷酸二氢钠水溶液（磷酸调pH=3.5）-乙腈（40∶60）为流动相,流速为1 mL/min,检测波长为213 nm。结果血浆中伪麻黄碱质量浓度在70～4 000μg/L范围内与峰面积比值线性关系良好（r=0.999 7）,最低检测浓度为0.012 5 mg/mL,方法提取率为69.01%。结论该方法具有较高的准确度,线性范围宽,方法灵敏,专一性好,操作简便,适用于盐酸伪麻黄碱血药浓度的测定及临床药代动力学研究。

HPLC determination of Pseudoephedrine Hydrochloride in Human Plasma

Objective To determine the concentration of pseudoephedrine hydrochloride in human plasma by HPLC with ultraviolet detec-tion.Methods The internal standard method was used.The evaluation of pseudoephedrine hydrochloride was carried out by ODS-C18 column（250 mm × 4.6 mm,5 μm） with the mobile phase of water containing 60 mmoL SDS,60 mol /L NaH2PO4（pH = 3.5）-acetonitrile（40 ∶ 60）,and the detection wavelength was 213 nm.The flow rate was 1 mL /min.Results The calibration curve for plasma pseudoephedrine hydrochloride was linear in range of 70-4 000 μg / L（r = 0.999 7）.The detection limit of pseudoephedrine hydrochloride was 0.012 5 mg / mL.The ex-traction rate was 69.01%.Conclusion This method is accurate,sensitive,specific and convenient,which could be used in the determination of plasma pseudoephedrine hydrochloride and its pharmacokinetic study in clinic.