HPLC测定消旋卡多曲的含量及杂质

Determination of racecadotril and its impurities by HPLC

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 ( 4.6 0cm× 2 5cm) ,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 10 0 0mL) ( 70∶30 )为流动相 ;检测波长为 2 10nm。结果 含量线性范围为 0 .0 8～ 0 .2 4mg·mL-1,回归方程为 Y =15 847X+ 3873(r =0 .9997) ,已知杂质benzylthiorphandisulphide线性范围为 2 .40～ 2 1.6 μg·mL-1,回归方程为Y=182 6X+ 46 (r =0 .9999) ,其最低检测浓度为 1μg·mL-1,加样平均回收率为 10 0 .0 % (n =6 )。结论 方法简便。

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&middotmL-1 and the regression equation was Y = 15847X + 3873(r = 0.9997). The liner range of benzylthiorphan disulphide was 2.40∼21.56 μg&middotmL-1 and the regression equation was Y = 1826x + 46 (r = 0.9999). The measurable lowest limit was 1 μg&middotmL-1. The average recovery was 100.0%. CONCLUSION: The method was convenient, accurate and specific.