Establishment of a Fast Chemical Identification System for screening of counterfeit drugs of macrolide antibiotics.
A Fast Chemical Identification System (FCIS) consisting of two colour reactions based on functional groups in molecules of macrolide antibiotics and two TLC methods was developed for screening of fake macrolide drugs. The active ingredients could be extracted from their oral preparations by absolute alcohol. Sulfuric acid reaction as a common reaction of macrolides was first used to distinguish the macrolides from other types of drugs and then 16-membered macrolides and 14-membered ones were distinguished by potassium permanganate reactions depending on the time of loss of colour in the test solution; after which a TLC method carried out on a GF(254) plate (5 cm x 10 cm) was chosen to further identification of the macrolides. The mobile phase A consisting of ethyl acetate, hexane and ammonia (100:15:15, v/v) was used for the identification of 14-membered macrolides, and the mobile phase B consisting of trichloromethane, methanol and ammonia (100:5:1, v/v) was used for the identification of 16-membered ones. A suspected counterfeit macrolide preparation can be identified within 40 min. The system can be used under different conditions and has the virtues of robustness, simplicity and speed.
Hu
Chang-Qin
CQ
National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, PR China. hucq@nicpbp.org.cn
Zou
Wen-Buo
WB
Hu
Wang-Sheng
WS
Ma
Xiao-Kang
XK
Yang
Min-Zhi
MZ
Zhou
Shi-Lin
SL
Sheng
Jin-Fang
JF
Li
Yuan
Y
Cheng
Shuang-Hong
SH
Xue
Jing
J
D000641:Ammonia / Q000032:analysis; D000900:Anti-Bacterial Agents / Q000032:analysis*; D002623:Chemistry Techniques, Analytical / Q000379:methods; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002725:Chloroform / Q000032:analysis; D002851:Chromatography, High Pressure Liquid; D002855:Chromatography, Thin Layer / Q000379:methods*; D003257:Consumer Product Safety; D004335:Drug and Narcotic Control / Q000379:methods*; D005607:Fraud / Q000517:prevention & control*; D006586:Hexanes / Q000032:analysis; D006868:Hydrolysis; D018942:Macrolides / Q000032:analysis*; D008956:Models, Chemical; D004364:Pharmaceutical Preparations / Q000032:analysis*; D011196:Potassium Permanganate / Q000032:analysis; D013464:Sulfuric Acids / Q000032:analysis
D000900:Anti-Bacterial Agents; D006586:Hexanes; D018942:Macrolides; D004364:Pharmaceutical Preparations; D013464:Sulfuric Acids; D011196:Potassium Permanganate; D000641:Ammonia; D002725:Chloroform; C033158:sulfuric acid