高效液相色谱法测定间尼索地平含量及有关物质  

HPLC determination of the content and the related substances of m-Nisoldipine

作　　者：吴华[1] 张兰桐[1] 袁志芳[1] 刘伟娜[1] 

机构地区：[1]河北医科大学药学院药物分析教研室,石家庄050017

出　　处：《药物分析杂志》2006年第6期799-801,共3页Chinese Journal of Pharmaceutical Analysis

基　　金：河北省药学重点学科资助项目

摘　　要：目的:建立间尼索地平含量测定及有关物质检查方法。方法:采用反相高效液相色谱法,色谱柱:SymmetryC_(18)柱(5μm,4.6mm×150mm),以甲醇-水(70:30)为流动相,流速为1.0mL·min^(-1),在237nm 波长下检测。结果:间尼索地平与各主要杂质及强制破坏产生的降解产物的杂质峰均分离良好;间尼索地平浓度在2.58×10^(-3)～0.644mg·mL^(-1)范围内,与峰面积呈良好的线性关系,r=0.9999(n=5);平均回收率为99.25%(RSD=0.47%,n=9);最低检测限为0.10ng。结论:该法专属性强,准确,灵敏,可用于间尼索地平的含量测定和有关物质检查。Objective：To establish a method to determine the content and related substances of m - nisoldipine. Method：RP - HPLC was used and chromatography condition was determined：the system was carried out using Symmetry C18 column and the mobile phase of methanol - water （70： 30） with flow rate of 1.0 mL ·min^-1 and the detection wavelength was at 237 nm. Results： The resolution between the peak of m - nisoldipine and other peaks was good. The linear range of the method was 2.58 ×10^-3～0. 644 mg ·mL^-1（ r = 0. 9999, n = 5 ） ; The average recovery was 99.25% （RSD =0. 47% ,n =9） and the limit of detection was 0. 10 ng. Conclusion：The method is specific, accurate, sensitive and can be used for the determination of m -nisoldipine.

关 键 词：高效液相色谱法 间尼索地平 含量测定 有关物质 

分 类 号：R917[医药卫生—药物分析学]