Determination of bisphenol diglycidyl ethers in topical dosage forms.
A method involving extraction and LC-ESI-MS-MS detection of BADGE, BFDGE, BADGE*H2O, BADGE*2H2O, BADGE*HCl, BADGE*H2O*HCl, BADGE.2HCl and BFDGE*2HCl in aqueous cream was developed and validated. Initially, empty internally lacquered aluminum container closure systems were extracted with isopropanol as an attempt to estimate the upper limit of extractable bisphenol diglycidyl ethers present in lacquer. Six of the eight potential bisphenol diglycidyl ethers were quantified. In an accelerated experiment, on aqueous cream stored in lacquered aluminum tubes at 70 degrees C, all derivatives except BADGE*2HCl and BFDGE*2HCl were extracted from cream samples and quantified as an attempt to estimate the upper limit of compounds leaching to the cream. Detection limits were from 0.3+/-0.2 to 3.4+/-0.7 microgl(-1). Recoveries were determined for all compounds at three concentration levels (mean 63+/-6%). Mean inter-day and mean intra-day precision was 7+/-2 and 13+/-6%, respectively. Three commercially available creams were obtained from a local community pharmacy and analysed for bisphenol diglycidyl ethers. BADGE, BADGE*H2O, BADGE*2H2O and BADGE*H2O*HCl were detected and quantified. In conclusion, the developed method allows for the extraction and detection of bisphenol diglycidyl ethers originating from the epoxy phenol lacquer used in aluminum tubes. This study does not indicate that they leach into aqueous cream in significant amounts under normal storage conditions.
Søeborg
Tue
T
Department of Analytical Chemistry, Danish University of Pharmaceutical Sciences, Universitetsparken 2, DK-2100 Copenhagen, Denmark. tes@dfuni.dk
Hansen
Steen Honoré
SH
Halling-Sørensen
Bent
B
D001559:Benzhydryl Compounds; D002853:Chromatography, Liquid / Q000379:methods*; D004340:Drug Contamination; D004349:Drug Packaging; D004852:Epoxy Compounds / Q000032:analysis*; D009824:Ointments; D004364:Pharmaceutical Preparations / Q000032:analysis*; D015203:Reproducibility of Results; D021241:Spectrometry, Mass, Electrospray Ionization; D013696:Temperature; D013997:Time Factors; D000098826:Bisphenol A Compounds
D001559:Benzhydryl Compounds; D004852:Epoxy Compounds; D009824:Ointments; D004364:Pharmaceutical Preparations; C019273:bisphenol A diglycidyl ether; D000098826:Bisphenol A Compounds; C423722:bisphenol F diglycidyl ether