HPLC法测定23-羟基白桦酸注射液中23-羟基白桦酸的含量

Determination of 23-hydroxylbetulinic acid in 23-Hydroxylbetulinic Acid Injection by HPLC

目的 建立 2 3-羟基白桦酸注射液中 2 3-羟基白桦酸的 HPL C分析方法。方法 采用 HPL C法。色谱柱 :YWG C1 8(2 5 0 mm× 4 .6 mm,10 μm) ;流动相 :乙腈 -水 -冰醋酸 (6 0 0∶ 4 0 0∶ 1) ;体积流量 :1.0 m L/ min;检测波长 :2 0 5 nm;柱温 :2 5℃ ;检测灵敏度 :0 .0 0 5 AU FS。采用外标法测定 2 3-羟基白桦酸的量。结果 2 3-羟基白桦酸在 10～10 0 μg与峰面积具有良好线性关系 ,平均回收率为 99.5 4 % ,RSD为 1.98% (n=5 )。结论 该方法快速、简便、准确可靠 ,可用于 2 3-羟基白桦酸的定量。

Object To establish a HPLC method for determination of 23-hydroxylbetulinic acid (23-HBA) content in 23-Hydroxylbetulinic Acid Injection (23-HBAI). Methods HPLC method was used with C 18 reverse phase column (250 mm×4.6 mm, 10 μm), acetonitrile-water-acetic acid (600∶400∶1) as mobile phase, velocity 1.0 mL/min, column temperature at 25 ℃, sensitivity 0.005 AUFS, detecting wave at 205 nm. Content of 23-HBA in 23-HBAI was determined with external standard method. Results The standard curves of 23-HBA showed good linearity over the range of 10—100 μg and the average recovery was 99.54% with RSD 1.98% (n=5). Conclusion The method is quick and simple, and it is accurate and reliable for the determination of 23-HBA.