高效液相二极管阵列检测法同时测定丹参粉针剂中4种水溶性成分的含量

Simultaneous determination of four water-soluble components in Danshen Powder for Injection by HPLC with DAD

目的:建立高效液相二极管阵列检测法同时测定丹参粉针剂中丹参素、原儿茶酸、原儿茶醛和迷迭香酸4种水溶性成分的含量。方法:采用DiamonsilTM C18色谱柱(250 mm×4.6 mm,5μm),以5%冰醋酸和甲醇为流动相进行梯度洗脱,柱温:30℃,流速为1.0 mL/min,检测波长为298 nm。结果:在此色谱条件下4种水溶性成分可完全分离。丹参素、原儿茶酸、原儿茶醛和迷迭香酸的线性范围分别为0.164 4～2.630μg(r=0.999 9),0.007 420～0.118 7μg(r=1.000 0),0.008 770～0.140 3μg(r=1.000 0),0.019 44～0.311 0μg(r=1.000 0)。平均回收率丹参素为101.6%(RSD为1.1%),原儿茶酸为102.2%(RSD为1.8%),原儿茶醛为101.3%(RSD为2.0%),迷迭香酸为100.9%(RSD为1.6%)。结论:本方法快速简便,4组分分离良好,可用于丹参粉针剂的质量控制。

AIM：To establish an HPLC with diode array detection for simultaneous determination of four water-soluble compounds： danshensu,protocatechuic aicd,protocatechuic aldehyde and rosmarinic acid in Danshen Pow-der for Injection.METHODS： The column was DiamonsilTM C18（250 mm × 4.6 mm,5 μm）.The mobile phase was methanol and 5% acetic acid glacial with gradient elution and the column temperature was 30 ℃,the flow rate was 1.0 mL/min,the detection wavelength was set up at 298 nm.RESULTS： The linearity was obtained over the ranges of 0.164 4-2.630 μg（r = 0.999 9） for danshensu with average recovery of 101.6%（RSD was 1.1%）,0.007 420-0.118 7 μg（r = 1.000 0） for protocatechuic aicd with average recovery of 102.2%（RSD was 1.8%）,0.008 770-0.140 3 μg（r = 1.000 0） for protocatechuic aldehyde with average recovery of 101.3%（RSD was 2.0%）,0.019 44-0.311 0 μg（r = 1.000 0） for rosmarinic acid with average recovery of 100.9%（RSD was 1.6%）.CONCLUSION： The method is rapid,simple,and reliable,and can be used to control the quality of Danshen Powder for Injection.