Salmani Jumah Masoud Mohammad, Wu Xue, Jacob Joe Antony, Fu Rong, Chen Baoan
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Acta Pharm. 2017 Sep 1;67(3):373-384. doi: 10.1515/acph-2017-0029.
In the current paper, an HPLC/UV method was developed and validated for determination of wogonin in plasma. Considerable attention was paid to the preparation of standard samples and factors affecting drug distribution. A preparation procedure was devised to simulate the conditions the drug is expected to experience in vivo while pointing to the shortcomings of previously published methods. The method was validated according to the FDA regulations and showed to be highly efficient and capable of extracting the drug and IS from the plasma accurately and precisely within the specified range of 50-500 ng mL-1. Further, the standard sample preparation of this method can be used as a guideline for other methods, particularly when highly hydrophobic drugs with considerable protein binding are involved and could be valuable in the field of bioanalysis to improve the reliability of methods.
在当前论文中，开发并验证了一种用于测定血浆中汉黄芩素的高效液相色谱/紫外检测法。对标准样品的制备以及影响药物分布的因素给予了相当多的关注。设计了一种制备程序来模拟药物在体内预期经历的条件，同时指出先前发表方法的缺点。该方法根据美国食品药品监督管理局（FDA）的规定进行了验证，结果表明在50 - 500 ng mL-1的指定范围内，该方法高效且能够准确、精密地从血浆中提取药物和内标物。此外，该方法的标准样品制备可作为其他方法的指导，特别是当涉及具有相当程度蛋白质结合的高疏水性药物时，在生物分析领域可能具有重要价值，有助于提高方法的可靠性。
