HPLC测定消旋卡多曲的含量及杂质

 目的建立新的高效液相法测定消旋卡多曲的含量及其杂质。方法采用C₁₈色谱柱(4.60cm×25 cm)，以乙腈磷酸二氢钾溶液(取磷酸二氢钾1g，加85%磷酸1mL，加水稀释至1000 mL)(70∶30)为流动相；检测波长为210 nm。结果含量线性范围为0.08～0.24 mg·mL^-1，回归方程为Y=15847X+3873(r=0.9997),已知杂质benzylthiorphan disulphide线性范围为2.40～21.6μg·mL^-1，回归方程为Y=1826X+46(r=0.9999)，其最低检测浓度为1μg·mL^-1，加样平均回收率为100.0%(n=6)。结论方法简便、快速准确。

Determination of racecadotril and its impurities by HPLC

OBJECTIVE　A HPLC method was established for the determination of racecadotril and its impurities.METHODS　A ODS column was used and the mixture of acetonitrile-potassium dihydrogen phosphate (KH2PO4) solution (70∶30) was used as the mobile phase.The detection wavelength was 210 nm.RESULTS　The liner range of the racecadotril was 0.08～0.24 mg*mL-1 and the regression equation was Y=15847X+3873(r=0.9997).The liner range of benzylthiorphan disulphide was 2.40～21.56 μg*mL-1 and the regression equation was Y=1826x+46 (r=0.9999).The measurable lowest limit was 1 μg*mL-1.The average recovery was 100.0%.CONCLUSION　The method was convenient,accurate and specific.