HPLC法测定复方氯硝柳胺片的含量

Determination of Compound Niclosamide Tablets by High Performance Liquid Chromatography

本文建立了测定复方氯硝柳胺片中氯硝柳胺和左旋咪唑的高效液相色谱法,采用Eclipse plus C-18(4.6×250 mm,5μm)色谱柱,流动相为甲醇:0.05 mol/L乙酸铵(70∶30,V/V),流速为1.0 mL/min,紫外检测波长为220 nm,柱温35℃。结果显示,氯硝柳胺在10μg/mL～800μg/mL,左旋咪唑在1μg/mL～80μg/mL范围内,浓度与峰面积积分值呈良好的线性相关,相关系数r分别为0.9998、0.9999;氯硝柳胺和左旋咪唑低、中、高三种浓度的平均回收率均在95.42%～101.12%之间,RSD在0.31%～1.48%之间;氯硝柳胺和左旋咪唑的定量限分别为1μg/mL、0.5μg/mL,检测限分别为0.4μg/mL和0.2μg/mL。结果表明,该方法快速、简洁、专属性强,回收率高,稳定性良好。

Niclosamid and Levamisole in Compound Niclosamide Tablets were determined by high performance liquid chromatography. The analytical column was Eclipse plus C18 column （4.6×250mm,5μm） with methanol - 0.05 moL/L ammonium acetate （70：30 by volume） as mobile phase at a flow rate of 1.0mL/min, the UV detection wavelength was 220 nm, column temperature was 35℃. The results showed that calibration curve of Niclosamid was linear between 10 and 800 μg/mL, with the correlation coefficient r = 0. 9998, calibration curve of Levamisole was linear between 1 and 80 μg/mL, with the correlation coefficient r = 0.9999. The recovery and relative standard deviation ranged from 95. 42% to 101. 12% and 0. 31% to 1. 48%, respectively. The limit of quantification of Niclosamid and Levamisole was 1 and 0.5μg/mL, respectively. The detection limit of Niclosamid and Levamisole was 0.4 μg/mL and 0.2 μg/mL, respectively. The detection method was suitable for detecting Niclosamid and Levamisole in compound niclosamide tablets.