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Validated HPLC method for ceftriaxone from dried blood spots for pharmacokinetic studies and therapeutic drug monitoring in neonatal population: supplementary data

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posted on 2023-05-22, 16:18 authored by Bhim B Chaudhari, Bhagyashree H Devadiga, Saikumar Matcha, Leslie ES Lewis, Surulivelrajan Mallayasamy, Sudheer Moorkoth

Background: 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. Method: 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. Results: 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. Conclusion: Observed concentrations

in clinical samples were comparable to the predicted concentrations, proving the clinical validity of the

method.

Funding

This work was supported by the All India Council for Technical Education, New Delhi, India, under the National Doctoral Fellowship Scheme (AICTE/NDF/PhD/2019/1-6389564801) and Manipal Academy of Higher Education under intramural funding (IMF-NDF/2019-200600003).m

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