HPLC法测定西尼地平及其片剂的含量

Determination of Cilnidipine and its Tablets by RP-HPLC

目的 建立起西尼地平有关物质检查及其片剂含量测定的 RP- HPL C方法。方法 色谱柱 :ShimpackODS柱 ,流动相 :甲醇 - 0 .0 3 mol/L 磷酸二氢钾水溶液 ( p H=3 .5 ,81∶ 19) ,检测波长 :2 40 nm,流速 :1.0 ml/m in。结果 西尼地平与有关物质完全分离 ,西尼地平在 1.6～ 3 0 0μg/m L范围内 ,峰面积与浓度线性关系良好 ,r=0 .9999,平均回收率 :99.78% ( n=9) ,RSD=0 .5 %。

AIM To establish a RP-HPLC method for determination of content of cilnidipine tablets and its related substances. METHOD The chromatographic procedure was carried out on a ODS column,using a mixture of 81% volumes of menthol and 19% volumes of 0.03 mol/L potassium dihydrogen orthophosphate(the pH adjusted to 3.5 with phosphase) as the mobile phase with a flow rate of 1.0 ml/min and ultraviolet detection wavelength at 240 nm. RESULTS Cilnidipine and the other components were separated completely under the selected chromatographic condition. The relationship between response and the concentration over the range of 1.6～300 μg/ml was linear with the correlation coefficient of 0.9999 and the average recovery was 99.78%( n =9,RSD=0.5%).CONCLUSION This method could be used in quality control of cilnidipine.