HPLC鉴定抗风湿中药制剂中非法添加的6种西药成分

Determination of Pharmaceutical Component in the Traditional Chinese Antirheumatic by RP-HPLC-DAD

关键词:  高效液相色谱法  二极管阵列检测器  醋酸泼尼松  醋酸地塞米松  萘普生  吲哚美辛  双氯芬酸钠  布洛芬  中药制剂

Key words:  HPLC  DAD  prednisone acetate  dexamethasone acetate  naproxen  indomethacin  diclofenacsodium  ibuprofen  traditional Chinese medicines

摘要:

目的 应用反相高效液相色谱-二极管阵列检测(RP-HPLC-DAD)技术分析检测抗风湿中药制剂中可能存在的西药成分。方法 采用的色谱柱分别为Kromasil KR100-5 C18 (4.6 mm´250 mm，5 µm)和Kromasil C8(4.6 mm´250 mm，5 µm)；流动相为甲醇-0.1%醋酸水溶液(60∶40)，流速：1 mL·min^-1，色谱检测波长230 nm。结果 为醋酸泼尼松、醋酸地塞米松、萘普生、吲哚美辛、双氯芬酸钠、布洛芬等6种成分，能在该色谱条件下得到分离和鉴定。结论 本方法可用于抗风湿中药制剂中西药成分的分析。

Abstract:

OBJECTIVE To determine pharmaceutical component in the traditional Chinese antirheumatic by reversed phase high performance liquid chromatography (RP-HPLC)-Photodiode Array Detector (DAD). METHODS The separation was performed on Kromasil KR100-5 C18 (4.6 mm´250 mm, 5 µm) and Kromasil C8(4.6 mm´250 mm, 5 µm) with detective wavelength at 230 nm. The mixture solution of methanol and 0.1% acetic acid (60∶40) was used as mobile phase with flow rate of 1.0 mL·min^-1. RESULTS Prednisone acetate, dexamethasone acetate, naproxen, indomethacin, diclofenac sodium and ibuprofen were proved to be separated completely under the selected chromatography conditions. CONCLUSION This method can be applied to determinate pharmaceutical component in traditional Chinese antirheumatic.