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Bioanalytical ICP-MS Method Validation for Determination of Zirconium in Human Urine
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| Author:
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CHAOYANG HUANG, JACK CHEN
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| Abstract:
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Zirconium compounds and alloys are being increasingly applied in pharmaceutical and medical applications because of their therapeutic roles and excellent biocompatibility. In this article, a method based on Inductively Coupled Plasma Mass Spectrometry (ICP-MS) is developed to quantify the concentration of zirconium in human urine in support of safety evaluation and biodistribution investigation in clinical studies of zirconium-containing drugs. Parallelism test showed good correlation between the matrix matched calibration and the calibration generated from diluent prepared standards, small difference (~4%) in slopes between the two curves occurred. Matrix matched calibration was used throughout the study. The developed ICP-MS method was validated following applicable bioanalytical guidance documents. The assessed parameters included sensitivity, selectivity, linearity, limit of quantitation, carryover, intra/inter-day accuracy and precision, capability of dilution, and sample stability upon benchtop and freeze thaw storage for certain periods. All test results yielded acceptable values that meet typical bioanalytical method validation requirements as set by the regulatory agencies.
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| Keyword:
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Inductively Coupled Plasma Mass Spectrometry, ICP-MS, Zirconium, Human Urine, Bioanalytical Method, Method Validation
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| EOI:
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| DOI:
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| Download:
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