The application of Ion chromatographic method for bioavailability and stability test of iron preparations |
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Authors: | Young -Ok Kim Hye -Joo Chung Hak -Soo Kong Don -Woong Choi Dae -Hyun Cho |
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Affiliation: | Department of Toxicology, NITR, Korea FDA, Nokbun-Dong, Eunpyung-Gu, Seoul. |
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Abstract: | 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. |
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Keywords: | Ion chromatography (IC) Bioavailability Stability AUC LOD Fe2+ Fe3+ |
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