高效液相色谱法测定人血清中伏立康唑的质量浓度

摘要

目的：建立测定人血清中伏立康唑浓度的高效液相色谱法，用于临床该药的治疗药物浓度监测。方法采用乙腈沉淀处理血清样品，采用高效液相色谱紫外检测法测定。以硝西泮为内标，色谱柱为 Hypersil ODS 柱（200 mm ×4.6 mm，5μm），流动相为25 mmol / L 磷酸二氢钾缓冲液－乙腈（32：68），流速为1.0 mL / min，柱温为35℃，波长为256 nm。结果伏立康唑质量浓度在0.3~12μg / mL 范围内与峰面积比线性关系良好( r =0.9993)，低、中、高质量浓度回收率分别为(105.0±3.6)%，(101.9±3.3)%，(101.1±3.4)%；日内、日间精密度的 RSD 均小于5%，定量限为0.3μg / mL。结论该方法简便快速、准确，适用于伏立康唑血药浓度的临床监测。%Objective To establish a HPLC method to determine the concentration of voriconazole in human plasma for its clinical ap-plication in the curative drug concentration monitoring. Methods The serum sample was performed the precipitation treatment by acte-tonitrile, then HPLC - UV was adopted for detection. With nitrazepan as the internal standard, the chromatographic column was the Hy-persil ODS columm (200. 0 mm × 4. 6 mm, 5 μm), the mobile phase was 25 mmol / L potassium dihydrogen phosphate buffer solution -acetonitrile ( 32 : 68 ) . The detection wavelength was at 256 nm with a flow rate of 1 mL / min and the column temperature of 35 ℃ . Results The concentration of voriconazole in the range of 0. 3 - 12 μg / mL( r = 0. 999 3) showed the good linearity. The recovery rates of low, middle and high concentrations were (105. 0 ± 3. 6)% , (101. 9 ± 3. 3)% and (101. 1 ± 3. 4)% , respectively. The intra - day and inter - day RSD were both less than 5% . The limit of quantitation was 0. 3 μg / mL. Conclusion The established method is fast, accu-rate and suitable for the determination of blood voriconazole concentration.