ABSTRACT
A simple, accurate and reliable method was presented and validated for the simultaneous monitoring of six phthalates at trace level concentrations in seven different brands of commercial bottled mineral water from Jordan. Liquid-liquid extraction with a mixture of methylene chloride-petroleum ether (20:80, v/v) was used for isolation and enrichment of the phthalates and sample cleanup. This was followed by gas chromatography-mass spectrometry (GC-MS) for identification and high-performance liquid chromatography (HPLC) with ultraviolet detection for quantification. The linear range of the GC-MS calibration curve was 0.3-1.2 µg/L with a mean correlation coefficient (R(2)) of 0.9920 ± 0.0063, the detection limit was < 0.1 µg/L and the percentage recovery was >90%. For HPLC, the linear range was 0.5-10 mg/L with R(2) = 0.9985 ± 0.0012 and an average detection limit of 0.20 ± 0.15 µg/L. The results indicated that the Jordanian bottled water was contaminated with dibutyl-, di-2-ethylhexyl- and di-n-octyl-phthalate, with total phthalate concentrations between 8.1 and 19.8 µg/L. Increasing the storage temperature of the bottled water increased the content of leached phthalates in the water (total concentration of 23-29.2 µg/L).
ABSTRACT
BACKGROUND: This study assessed the relative bioavailability of two formulations of ibuprofen. The first formulation was Doloraz(®), produced by Al-Razi Pharmaceutical Company, Amman, Jordan. The second forumulation was Brufen(®), manufactured by Boots Company, Nottingham, UK. METHODS AND RESULTS: A prestudy validation of ibuprofen demonstrated long-term stability, freeze-thaw stability, precision, and accuracy. Twenty-four healthy volunteers were enrolled in this study. After overnight fasting, the two formulations (test and reference) of ibuprofen (100 mg ibuprofen/5 mL suspension) were administered as a single dose on two treatment days separated by a one-week washout period. After dosing, serial blood samples were drawn for a period of 14 hours. Serum harvested from the blood samples was analyzed for the presence of ibuprofen by high-pressure liquid chromatography with ultraviolet detection. Pharmacokinetic parameters were determined from serum concentrations for both formulations. The 90% confidence intervals of the ln-transformed test/reference treatment ratios for peak plasma concentration and area under the concentration-time curve (AUC) parameters were found to be within the predetermined acceptable interval of 80%-125% set by the US Food and Drug Administration. CONCLUSION: Analysis of variance for peak plasma concentrations and AUC parameters showed no significant difference between the two formulations and, therefore, Doloraz was considered bioequivalent to Brufen.
