HPLC法同时测定马来酸依那普利与尼群地平的含量

Content determination of enalapril maleate and nitrendipine by HPLC

目的建立以高效液相色谱法测定复方尼群地平片中马来酸依那普利与尼群地平含量的方法。方法色谱柱为Kromasil C_(18)柱(4.6 mm×250 mm,5μm),甲醇-磷酸盐缓冲液(0.01 mol/L磷酸二氢钾溶液,用磷酸调p H值为3.0)(65∶35)为流动相,流速0.8 m L/min,检测波长为215 nm,柱温50℃,进样量为20μL。结果马来酸依那普利在10.16~193.04 mg/L浓度范围内线性关系良好(R^2=0.999 7),平均加样回收率为100.28%;尼群地平在20.96~338.24 mg/L浓度范围内线性关系良好(R2=0.999 8),平均加样回收率为99.54%。结论该方法可用于同时测定复方尼群地平片中马来酸依那普利、尼群地平的含量。

Objective To establish an HPLC method for the content determination of enalapril maleate and nitrendipine in compound nitrendipine tablet. Methods Samples were determined on a Kromasil C_（18）column（ 4. 6 mm×250 mm,5 μm）,the mobile phase consisted of methanol-phosphate buffer（ 0. 01 mol / L potassiumdihydrogen phosphate solution adjusted with phosphoric acid to a p H of 3. 0）（ 65∶ 35） with flowrate at 0. 8 mL / min,the UV detection wavelength was 215 nm,column temperature was 50 ℃,and sample size was 20 μL. Results The linear range of enalapril maleate was 10. 16 ~ 193. 04 mg / L（ R^2= 0. 999 7）,the average recovery rate was 100. 28%; the linear range of nitrendipine was 20. 96 ~ 338. 24 mg / L（ R^2= 0. 999 8）,the average recovery rate was 99. 54%. Conclusion The method is accurate for the simultaneous determination of enalapril maleate and nitrendipine in the compound nitrendipine tablet.