内标HPLC法测定注射用盐酸地尔硫含量

Ditermination of diltiazem hydrochloride for injection by internal Standard

目的建立注射用盐酸地尔硫含量的内标高效液相色谱测定法。方法以苯甲酸苯酯作为内标,DiamonsilODS柱(4.6mm×250mm,5μm)分离,α-樟脑磺酸-醋酸钠缓冲液-乙腈-甲醇(25∶40∶35)作为流动相,柱温50℃,流速1.2mL/min,检测波长为240nm。结果盐酸地尔硫卓艹的线性范围为0.1007～0.5035mg/mL,平均回收率为97.85%,RSD=0.799%(n=9)。结论内标HPLC法测定注射用盐酸地尔硫含量,方法简便、快速和准确,可用于该制剂的质量控制。

[Objective] To estabhsh an HPLC method of determination of diltiazem hydrochloride. [Methods] Chromatographic conditions included Diamonsil ODS C18 column was used with 50℃ column temperature and a mobile phase of α-caphor-sulfonic acid-sodium acetate buffer-solution -acetonitrile-methanol （25：40：35） at a flow rate of 1.2 mL/min and 240 nm detection, and phenyl benzoate was used as internal standard. [Results] The linear of diltiazem hydrochloride was 0.1007～0.5035 mg/mL, the recovery was 97.85%,RSD=0.799% （n=9）. [ Conclusions] This methods is simple, rapid, accurate and reliable.