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目的建立用高效液相色谱法测定盐酸左旋咪唑片的含量及溶出度的方法。方法采用反相高效液相色谱法,以Diamonsil C18柱(250mm×4.6mm,粒直径5μm)为固定相;0.05mol/L磷酸二氢钾-乙腈(80:20)为流动相;流速为1.0ml/min;检测波长为214nm;柱温:25℃。结果盐酸左旋咪唑在1～50μg/m(lr=0.9999)范围内呈良好的线性关系,平均回收率为99.6%(n=6),溶出量30min内大于标示量的80%。结论所建立的方法准确、可靠、重现性好,适用于盐酸左旋咪唑片的质量控制。
Objective To establish a HPLC method for the determination of levamisole hydrochloride tablets and dissolution. Methods Diamonsil C18 column (250 mm × 4.6 mm, particle size 5 μm) was used as the stationary phase. The mobile phase was 0.05 mol / L potassium dihydrogen phosphate - acetonitrile (80:20). The flow rate was 1.0 ml / min; detection wavelength was 214nm; column temperature: 25 ℃. Results The levamisole hydrochloride showed a good linearity in the range of 1 ~ 50μg / m (lr = 0.9999) with an average recovery of 99.6% (n = 6). The dissolution rate was greater than 80% of the labeled amount in 30 min. Conclusion The established method is accurate, reliable and reproducible. It is suitable for the quality control of levamisole hydrochloride tablets.