The application of ion chromatographic method for bioavailability and stability test of iron preparations.
Postabsorptive serum iron level was determined after oral administration of the compounds to human. In serum and whole blood, Fe3+ was measured by ion chromatography (IC) using a pyridine-2,6-dicarboxylic acid (PDCA) as an eluent. The serum sample solutions were pretreated with I N HCI and 50% TCA. The whole blood sample solutions were treated with 3 N HCI for 30 min at 125 degrees C. The limit of detection (LOD) of the IC technique is 0.2 microM for Fe2- and 0.1 microM for Fe3+. The area under concentration (AUC) can be obtained by the above analytical condition. In addition, to compare the stability of Fe2+ to that of Fe3+ in pharmaceutical preparations, accelerated stability test was carried out. After storing the samples under 40 degrees C, 75%RH in light-resistant container for various time intervals, the contents of iron of different valencies were determined separately by the IC technique and the change and/or the interchange of among those iron species in preparations was investigated. Iron raw materials are stable, but Fe2+ in Fe3+ source materials was slightly converted to Fe3+ by oxidation. Fe2+ in Fe3+ source raw materials and Fe3+ in Fe2+ raw materials are determined as impurities. Therefore, IC technique is found to be an appropriate method for comparative evaluation of dissimilar bioavailability of Fe2+ and Fe3+, stability of Fe2+ and Fe3+ raw materials and preparations.
Kim
Y O
YO
Department of Toxicology, NITR, Korea FDA, Nokbun-Dong, Eunpyung-Gu, Seoul.
Chung
H J
HJ
Kong
H S
HS
Choi
D W
DW
Cho
D H
DH
D001682:Biological Availability; D002852:Chromatography, Ion Exchange / Q000295:instrumentation / Q000379:methods*; D004355:Drug Stability; D005290:Ferric Compounds / Q000378:metabolism*; D005296:Ferrous Compounds / Q000378:metabolism*; D006358:Hot Temperature; D006801:Humans; D006813:Humidity; D007501:Iron / Q000097:blood*; D008027:Light; D011725:Pyridines / Q000737:chemistry; D012680:Sensitivity and Specificity
D005290:Ferric Compounds; D005296:Ferrous Compounds; D011725:Pyridines; D007501:Iron