"For export only" medicines come back to Europe: a RP-LC method for the screening of six glucocorticoids in illegal and counterfeit anti-inflammatory and lightening creams.
"For export only" anti-inflammatory and lightening creams are medicinal products sold in African countries for their skin whitening action. In the last years, Rapid Alerts from European Medicinal Regulatory Agencies evidenced the presence of a large number of illegal and counterfeit anti-inflammatory products advertised for their whitening action on black skin in the European market. These drugs, containing glucocorticoids, are illegally sold in Europe in unauthorized ethno-cosmetics-shops and mainly bought by immigrants. This paper reports a new RP-LC method for the rapid simultaneous screening of six different active ingredients in anti-inflammatory and whitening products (creams, ointment and suspension): betamethasone dipropionate, dexamethasone, fluocinonide, fluocinolone acetonide, clobetasol propionate, methyl-prednisolone acetate. The method was developed and validated in view of its possible application in quality control laboratories, mainly those appointed to the control of illegal/counterfeit medicinal products. The associated measurement uncertainty was calculated from validation data. The method was then applied to the analysis of whitening products obtained from the Italian illegal market.
Gaudiano
M C
MC
Dipartimento del Farmaco, Istituto Superiore di Sanità, Viale Regina Elena, 299, 00161 Rome, Italy.
Lucente
D
D
Antoniella
E
E
Bertocchi
P
P
Muleri
N
N
Manna
L
L
Bartolomei
M
M
Alimonti
S
S
Valvo
L
L
Rodomonte
A L
AL
D000893:Anti-Inflammatory Agents / Q000032:analysis*; D056148:Chromatography, Reverse-Phase / Q000379:methods*; D004304:Dosage Forms; D005607:Fraud; D005938:Glucocorticoids / Q000032:analysis*; D009824:Ointments / Q000737:chemistry
D000893:Anti-Inflammatory Agents; D004304:Dosage Forms; D005938:Glucocorticoids; D009824:Ointments