用于新生儿群体药代动力学研究和治疗药物监测的干血斑中头孢曲松的验证 HPLC 方法。
Validated HPLC method for ceftriaxone from dried blood spots for pharmacokinetic studies and therapeutic drug monitoring in neonatal population.
机构信息
Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, 576104, India.
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, 576104, India.
出版信息
Bioanalysis. 2023 Apr;15(8):449-463. doi: 10.4155/bio-2023-0047. Epub 2023 May 22.
Pharmacokinetic evaluation is essential for the precise dosing of ceftriaxone in neonates. There is a need for developing a sensitive, affordable and convenient analytical method that can estimate ceftriaxone from dried blood spot (DBS) samples of neonates. An HPLC-UV method was developed and validated as per ICH M10 for ceftriaxone from DBS and plasma using an Inertsil-ODS-3V column with gradient elution. DBS samples were extracted with methanol. Clinical validation was performed using neonatal samples. The developed plasma- and DBS-based-HPLC method were linear from 2-700 μg/ml and 2-500 μg/ml, respectively, for ceftriaxone. Bland-Altman analysis indicated a strong interconvertibility between the plasma and DBS assays. Observed concentrations in clinical samples were comparable to the predicted concentrations, proving the clinical validity of the method.
药代动力学评估对于新生儿头孢曲松的精确给药至关重要。需要开发一种灵敏、经济实惠且方便的分析方法，能够从新生儿干血斑（DBS）样本中估算头孢曲松的浓度。 我们开发了一种 HPLC-UV 方法，并按照 ICH M10 进行了验证，可用于从 DBS 和血浆中使用 Inertsil-ODS-3V 柱进行梯度洗脱来检测头孢曲松。DBS 样本用甲醇提取。使用新生儿样本进行了临床验证。 所开发的基于血浆和 DBS 的 HPLC 方法对头孢曲松的线性范围分别为 2-700μg/ml 和 2-500μg/ml。Bland-Altman 分析表明，血浆和 DBS 检测之间具有很强的可转换性。 临床样本中的观察浓度与预测浓度相当，证明了该方法的临床有效性。
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