高效液相色谱法测定盐酸地尔硫注射液的含量

Determination of diltiazem hydrochloride injection by high-performance liquid chromatography

目的：建立高效液相色谱法测定盐酸地尔硫[艹卓]注射液的含量。方法：采用NUCLEODUR C18柱，以缓冲液（pH6．2）-乙腈-甲醇（40：30：30）为流动相，检测波长为240nm。结果：本色谱条件能分离盐酸地尔硫[艹卓]及有关物质；在4～200mg／L浓度范围内，盐酸地尔硫[艹卓]的峰面积与其浓度呈线性关系，方法平均回收率为100．22％，RSD为0．37％。结论：本法可用于盐酸地尔硫[艹卓]注射液的含量测定。

Objective To establish an high-performance liquid chromatography （HPLC） method for the determination of diltiazem hydrochloride injection. Methods The assay was conducted on a NUCLEODUR C18 column with buffer solution （ pH6. 2 ） -acetonitrile-methanol （40： 30：30 ） as the mobile phase and the detection wavelength was 240 nm. Results Dihiazem hydrochloride and relevant substances could be separated under the condition. The linear concentration range of diltiazem hydrochloride was 4 - 200 mg/L with the recovery of 100.22% （ RSD = 0.37% ） . Conclusion The method may be used for the determination of diltiazem hydrochloride injection.