高效液相色谱法测定盐酸地尔硫革延迟释放片的含量

Quantification of the delayed-release tablets of diltiazem hydrochloride by HPLC

目的:建立测定盐酸地尔硫(艹卓)延迟释放片含量的方法。方法:采用高效液相色谱法,色谱柱为Dikma ODS柱(250mm×4.6mm,5μm);流动相为乙腈-甲醇-0.02mol·L^(-1)醋酸铵溶液(5:2:3),流速:1.0mL·min^(-1);检测波长:240nm;柱温:室温;外标法峰面积定量。结果:盐酸地尔硫(艹卓)保留时间约为7.73min,辅料对主药测定无干扰。盐酸地尔硫(艹卓)浓度在20～220μg·mL^(-1)(r=0.9980),标准曲线范围线性关系良好,最低检测限为8.4ng,平均回收率为100.6%～101.6%(n=3)。结论:本法专属性强,操作方便,结果准确,重现性好。

Objective:To establish a HPLC method for the determination of the delayed-release tablets of diltiazem hydrochloride. Methods: The HPLC conditions were as followed: a Dikma ODS (250mm×4. 6mm,5μm) as the chromatography column with room temperature, UV detection at 240nm,a buffer solution containing the mixture of acetonitrile-methyl alcohol-0. 02mol·L^(-1) ammoium acetate solution (5:2:3) as the mobile phase,the elution rate at l.0mL·min. Results:The correlation of the linear range was shown within 20 and 220μg·mL^(-1)(r=0.9980).The limit of quantification was 8. 4ng. The mean recovery rate was 100. 6% ~ 101. 6% (n=3). Conclusion: The optimal HPLC condition is simple,accuracy,reproducible and highly selective.