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目的用高效液相色谱法测定复方甲苯咪唑片剂中甲苯咪唑和盐酸左旋咪唑的含量。方法采用高效液相色谱法,使用C18(200mm×4.6mm5μm)色谱柱,以甲醇-0.5%醋酸胺为流动相。线性梯度洗脱,流速1.0mL?min-1,检测波长227nm。结果甲苯咪唑在50～250μg?mL-1范围内线性较好,其线性方程为C=-1.9875+1.6975×10-4A(n=5,r=0.9998);盐酸左旋咪唑在12.5～62.5μg?mL-1范围内线性较好,其线性方程为C=-1.9658+1.6995×10-5A(n=5,r=0.9998)。甲苯咪唑的平均回收率为99.5%RSD=0.4%(n=9),盐酸左旋咪唑的平均回收率为98.6%RSD=0.5%(n=9)。结论高效液相色谱法快速简捷、可靠、准确度高、重现性好,可同时测定复方制剂中两种成分。
Objective To determine the content of mebendazole and levamisole in compound mebendazole tablets by high performance liquid chromatography. Methods High performance liquid chromatography (HPLC) with C18 (200 mm × 4.6 mm 5 μm) column and methanol-0.5% ammonium acetate as mobile phase was used. Linear gradient elution, flow rate 1.0mL? Min-1, detection wavelength of 227nm. Results The linear range of mebendazole in the range of 50 ~ 250μg? ML-1 was C = -1.9875 + 1.6975 × 10-4A (n = 5, r = 0.9998) mL-1, the linear equation was C = -1.9658 + 1.6995 × 10-5A (n = 5, r = 0.9998). The mean recoveries of mebendazole were 99.5% RSD = 0.4% (n = 9) and the average recovery of levamisole hydrochloride was 98.6% RSD = 0.5% (n = 9). Conclusion HPLC is fast, simple, reliable, accurate and reproducible. It can be used for the simultaneous determination of two components in compound preparations.