香丹注射液中丹酚酸B的HPLC法测定

Determination of Salvianolic Acid B in Xiangdan Injection by HPLC

建立了1种测定香丹注射液中丹酚酸B含量的反相高效液相色谱法;色谱分析柱为Hypersil ODS(4.6mm×250 mm,5 μm),流动相为甲醇-乙腈-甲酸-水(体积比27:9:1.1:62.9,含10 mmol/L的四丁基溴化铵),检测波长为285 nm,流速为1.0 mL/min,柱温为31℃时,丹酚酸B得到较好的分离;丹酚酸B进样量在0.264～1.584μg范围内线性良好,r=0.999 8,方法平均回收率为98%,为香丹注射液质量控制提供了分析方法.

A gradient reversed-phase high performance liquid chromatography （RP-HPLC） was developed for the separation of salvianolic acid B from Xiangdan injection. Chromatographic separation was performed with a Hypersil ODS column（4.6 mm × 250 mm, 5 μm） at 31℃ with a mobile phase consisting of methanolacetonitrile-aminic acid-water（27 ： 9 ： 1.1 ： 62.9 by volume, 10 mmol/L tetrabutylammonium bromide） at a flow rate of 1.0 mL/min, the mobile phase was monitored by a photodiode array detector at 285 nm. The linear range for the detection of salvianolic acid B was 0. 264-1. 584μg（ r = 0. 999 8）, and the average recovery of the method was 98 %. This method can be used for the quantification of salvianolic acid B in Xiangdan injection.