RP-HPLC法测定香丹注射液中丹酚酸A的含量

RP - HPLC Analysis of Salvianolic Acid A in Xiangdan Injection

目的:控制香丹注射液的质量。方法:建立高效液相色谱法测定香丹注射液中丹酚酸A的含量。色谱柱为Luna C_(18)(2)色谱柱(4.6mm×15cm,5μm),流动相为甲醇-水-甲酸(41:59:0.8),检测波长为285nm,流速为1.0mL·min^(-1),柱温25℃。结果:丹酚酸A进样量在0.24～5.6μg范围内线性良好,r=0.9997,理论板数5.5×10~3,方法平均回收率为101.3％。应用本法测定了5个厂家生产的香丹注射液,含量范围为0～1.148mg·mL^(-1)。结论:本法操作简单,结果可靠,可作为香丹注射液的常规检验方法。

Objective: Studies on quality control of Xiangdan injection. Methods: The content of salvianolic acid A was determined by RP - HPLC. Luna C18 (2) column (4. 6 mm × 15 cm, 5 μm) was used with a mobile phase of methanol - water - aminic acid (41 : 59: 0. 8 ) and detected at 285 nm. The flow rate was 1. 0 mL · min - 1. Results: The range of linearity is 0. 24 - 5. 6 μg salvianolic acid A ( r = 0. 999 7 ). The theoretical plate number is 5. 5 ×103. The average recovery is 101. 3% . The contents of salvianolic acid A in Xiangdan injections froni five factories were measured with the above method. The range of contents was 0 - 1. 148 mg · mL-1 . Con-clusion: The established method is simple, reliable and suitable for the usual quality control method of Xiangdan injection.