用于控制药用级 L-丙氨酸纯度的氨基酸分析替代方法。
Alternatives to amino acid analysis for the purity control of pharmaceutical grade L-alanine.
机构信息
University of Wuerzburg, Institute of Pharmacy and Food Chemistry, Wuerzburg, Germany.
出版信息
J Sep Sci. 2010 Aug;33(16):2402-10. doi: 10.1002/jssc.201000141.
The quality control of drugs is important for safety of patients and consumers. International pharmacopoeias mostly employed HPLC with UV detection for this purpose. This is always a problem when the drugs, such as most amino acids, are lacking a chromophor. Instead of UV detection, the impurity control of alanine was performed using charged aerosol detector, evaporative light-scattering detector, nano quantity analyte detector, MS detector, and as an orthogonal method, quantitative NMR spectroscopy. The charged aerosol detector, MS detector, and quantitative NMR spectroscopy provided similar and precise results, whereas the evaporative light-scattering detector and nano quantity analyte detector revealed some problems regarding sensitivity, linearity, and robustness.
药品质量控制对于患者和消费者的安全至关重要。为此，大多数国际药典都采用高效液相色谱法（HPLC）结合紫外检测法。然而，当药物（如大多数氨基酸）缺乏发色团时，这就成了一个问题。本文以丙氨酸为例，采用了荷电气溶胶检测器、蒸发光散射检测器、纳米量分析物检测器、MS 检测器，并作为正交方法采用定量 NMR 光谱法，对其杂质控制进行了研究。结果表明，荷电气溶胶检测器、MS 检测器和定量 NMR 光谱法提供了相似且精确的结果，而蒸发光散射检测器和纳米量分析物检测器在灵敏度、线性度和稳健性方面存在一些问题。
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