HPLC法测定呋喃妥因肠溶片的含量

目的: 建立HPLC法测定呋喃妥因的含量。 方法: 色谱柱为Diamonsil C₁₈(4.6 mm×150 mm,5 μm),流动相为水–甲醇(55∶ 45),检测波长367 nm,流速1.0 mL·min^-1,进样量20 μL。 结果: 呋喃妥因进样量在2~16 μg ·mL^-1范围内线性关系良好(r=0.9996,n=6)平均回收率99.7%,RSD=0.71(n=9)。 结论: 本方法简便,准确,重复性好,可用于呋喃妥因片剂的含量测定。

Objective: To establish a method of determination of nitrofurantoin enteric-coated tablets by RP-HPLC. Method: RP-HPLC was used Diamonsil C₁₈ column(4.6 mm×150 mm,5 μm),mobile phase was composed of methanol-water(55∶ 45),The flow rate was 1.0 mL·min^-1 with detection wavelength at 367 nm. Result: The linear range of phneytoin sodium was 2–16 μg·mL^-1(r=0.9996,n=6). The average recovery was 99.7% and RSD was 0.71(n=9). Conclusion: The method is simple,accurate and suitable.