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題名 | Development and Validation of an HPLC Method for the Purity Assay of BZM, the Precursor of Striatal Dopaminergic D2/D3 Receptor SPECT Imaging Agent [123I]IBZM (Iodobenzamide)=多巴胺D2/D3受體造影劑IBZM前驅物BZM純度分析與確效研究 |
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作者姓名(中文) | 劉公典; 楊漢興; 夏儀芝; 楊安水; 蘇昌永; 林台生; 沈立漢; | 書刊名 | 藥物食品分析 |
卷期 | 16:5 2008.10[民97.10] |
頁次 | 頁28-38+104 |
分類號 | 418.346 |
關鍵詞 | 純度分析; 方法確效; MRM轉移; 碎裂路徑; BZM; IBZM; [123I]IBZM; RP-HPLC; LC-ESI-MS/MS; Purity assay; Method validation; MRM transition; Fragmentation pathway; |
語文 | 英文(English) |
英文摘要 | We developed and validated a reverse-phase high performance liquid chromatography (RP-HPLC) method for the purity assay of BZM. BZM is a precursor and free ligand of [123I]IBZM (iodobenzamide) that is a SPECT imaging agent for striatal dopaminergic D2/D3 receptor (D2R). The chromatographic separation was achieved on a Zorbax Eclipse XDB-C18 column with a gradient mobile phase consisting of 10 mM ammonium acetate buffer, pH 7.0 and acetonitrile at a flow rate of 0.5 mL/min. The absorbance at 254 nm against the concentration of BZM over the range 0.5-5.5 μg was linear, with a correlation coefficient above 0.9997. The limit of detection (LOD) and quantification (LOQ) of major impurity (impurity A, tR = 3.85 min) in BZM were 0.028% and 0.094%, respectively. Method validation parameters, including specificity, precision, accuracy, linearity, LOD/LOQ, robustness and solution stability were evaluated, indicating the potential of this method in pharmaceutical quality control. Moreover, the most sensitive precursor to product ion transitions for the identification of BZM and ‘cold’ IBZM by LC-ESI-MS/MS were found to be m/z 279.0-112.0 and 405.0-112.0, respectively. The present results allow identification of fragmentation ions and proposition of the pathways of BZM and ‘cold’ IBZM, showing that the feasibility of this method for quantification of free ligand BZM in SPECT imaging agent [123I]IBZM injection. |
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