Establishment of an HPLC identification system for detection of counterfeit steroidal drugs.
A set of simple HPLC methods employing UV detection were developed for detection of counterfeit drugs by the qualitative and quantitative analysis of nine steroidal drugs, ethinylestradiol, diethylstilbestrol, norethisterone, norgestrel, methyltestosterone, medroxyprogesterone acetate, progesterone, testosterone propionate and nilestriol. The methods were based on studies of the relationships between the retention factors (k) of the nine compounds and the percentages of water to methanol in the mobile phases on a reverse phase Alltima C(18) column giving reliable separation of the compounds under three sets of chromatographic conditions. The methods were validated using statistical tests and were used on nine commercial samples for detection of possible counterfeit drugs.
Shi
Ya-Qin
YQ
National Institute for Control of Pharmaceutical and Biological Products, 2 Tiantan Xili, Beijing 100050, China.
Yao
Jing
J
Liu
Feng
F
Hu
Chang-Qin
CQ
Yuan
Jun
J
Zhang
Qi-Ming
QM
Jin
Shao-Hong
SH
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004054:Diethylstilbestrol / Q000032:analysis; D004964:Estriol / Q000031:analogs & derivatives / Q000032:analysis; D004997:Ethinyl Estradiol / Q000032:analysis; D017258:Medroxyprogesterone Acetate / Q000032:analysis; D008777:Methyltestosterone / Q000032:analysis; D009644:Norgestrel / Q000032:analysis; D011374:Progesterone / Q000032:analysis; D011800:Quinestrol / Q000031:analogs & derivatives; D012680:Sensitivity and Specificity; D013256:Steroids / Q000032:analysis*; D043343:Testosterone Propionate / Q000032:analysis
D013256:Steroids; D009644:Norgestrel; D004997:Ethinyl Estradiol; D011374:Progesterone; D004054:Diethylstilbestrol; C010722:nylestriol; D017258:Medroxyprogesterone Acetate; D004964:Estriol; D011800:Quinestrol; D008777:Methyltestosterone; D043343:Testosterone Propionate