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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: To control the quality of Xiangdan injection. Methods: A HPLC method was established for the determination of salvianolic acid A in Xiangdan injection. The column was a Luna C_(18)(2) column (4.6 mm×15 cm, 5 μm). The mobile phase was methanol-water-formic acid (41:59:0.8). The detection wavelength was 285 nm and the flow rate was 1.0 mL·min. (-1), column temperature 25°C. Results: The calibration curve of salvianolic acid A in the range of 0.24～5.6μg showed good linearity, r=0.9997, theoretical plate number 5.5×10~3. The average recovery rate of the method was 101.3%. The method was applied to determine the Xiangdan injection produced by 5 manufacturers, and the content ranged from 0 to 1.148 mg·mL~(-1). Conclusion: This method is simple, reliable, and can be used as a routine test method for Xiangdan injection.