HP LC法测定盐酸左旋咪唑粉中盐酸左旋咪唑的含量

摘要

建立了盐酸左旋咪唑粉中盐酸左旋咪唑含量的高效液相色谱测定法。以0．05 mol／L磷酸二氢钾（用三乙胺调节pH值为7）－乙腈（80∶20）为流动相，盐酸左旋咪唑经C18色谱柱分离，在214 nm波长下检测。试验结果表明，盐酸左旋咪唑在0．1～2．0 mg／mL范围内线性关系良好，R2＝0．9995，平均回收率为101．3％（ n＝6），RSD为0．6％。本方法简便、准确、重现性好，可更好的控制盐酸左旋咪唑粉的质量。%The method for determination of levamisole hydrochloride in levamisole hydrochloride powder by HPLC was developed. The analyte was separated on C18 chromatographic column using a mobile phase of potassium dihydrogen phosphate (0.05 mol/L,pH value adjusted to 7.0 with triethylamine)-acetonitrile (80 ∶ 20), and detected at the wavelength of 214 nm. The method was validated for specificity,accuracy,linearity, precision and robustness.The results showed that a good linear relationship was accepted in the range of 0.1~2.0 mg/mL (R2=0.9995) , and the average recovery was 101.3% ( n=6) , and the RSD value was 0.6%. This method was suited to control the quality of levamisole hydrochloride powder.