金丝桃素注射剂的制备及其含量的测定

Preparation and content determination of hypericin injection

采用高效液相色谱法（HPLC法）测定所制备的金丝桃注射液中金丝桃素的含量,测定时采用Chrom-sphere C18（4.6 mm×150 mm,5μm）色谱柱,流动相为甲醇-乙腈-1%磷酸盐缓冲液（v/v/v=170∶10∶10）,流速为1 mL/min,检测波长588 nm.结果表明：线性范围为0.04~0.20μg,金丝桃素的含量是0.21%（相当于每毫升注射液含金丝桃素0.009 3 mg）,RSD为1.07%.HPLC法灵敏、准确、重现性好,可用于金丝桃素注射液含量的测定.

HPLC method was established for the determination of hypericin injection. The Chromsphere C18（4.6 × 150 mm, 5 μm）column was used to determine the content of hypericin,and the mobile phase was methanol-acetonitrile-1 %phosphate buffer（170 ： 10 ： 10）,the flow rate of 1ml/min and detection wavelength at 588 nm. The results showed that the calibration curve was linear within the quality range of 0.04-0.20 μg and hypericin content was 0.21 %（equivalent to 1 mL injection containing 0.009 3 mg hypericin） ,RSD was 1.07 %. It is suggest that HPLC could be used for ananlysis of compound hypericin injection with sensitive,accurate and highly reproductive.