TY - JOUR
T1 - A comparative evaluation of the plasma and DBS-based LC-MS/MS methods for the simultaneous analysis of nine antibiotics for application to pharmacokinetic evaluations and precision dosing in neonates
AU - Chaudhari, Bhim Bahadur
AU - Lewis, Leslie E.
AU - Rajan, M. Surulivel
AU - Gupta, Ashutosh
AU - Saha, Moumita
AU - Kunkalienkar, Shivani
AU - Moorkoth, Sudheer
N1 - Publisher Copyright:
© 2025 Bhim Bahadur Chaudhari et al. This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).
PY - 2025
Y1 - 2025
N2 - Precise dosing of antibiotics in the neonatal population is a challenge due to insufficient pharmacokinetic data in neonates. The lack of suitable analytical methods is a roadblock to achieving this goal. The aim of the present study is to develop simultaneous LC-MS/MS methods for nine antibiotics from the neonatal plasma and dried blood spot samples and to compare them for their sensitivity, selectivity, accuracy, and other related validation parameters. The chromatographic separation was obtained using Acclaim120 C18 (150 × 4.6 mm, 3 µ) column on an LTQXL linear ion trap LC-MS/MS with a gradient program. The method was fully validated as per the ICHM10 guideline. The method has successfully passed all the validation criteria including the matrix effect, carry over, dilution integrity, and has shown reproducible recovery on extraction from plasma. The results of the stability studies were satisfactory, and the method was successfully applied for the analysis of clinical samples. In contrast to the plasma method, the DBS method failed to show linearity and is not suggestive for analysis of the selected antibiotics.
AB - Precise dosing of antibiotics in the neonatal population is a challenge due to insufficient pharmacokinetic data in neonates. The lack of suitable analytical methods is a roadblock to achieving this goal. The aim of the present study is to develop simultaneous LC-MS/MS methods for nine antibiotics from the neonatal plasma and dried blood spot samples and to compare them for their sensitivity, selectivity, accuracy, and other related validation parameters. The chromatographic separation was obtained using Acclaim120 C18 (150 × 4.6 mm, 3 µ) column on an LTQXL linear ion trap LC-MS/MS with a gradient program. The method was fully validated as per the ICHM10 guideline. The method has successfully passed all the validation criteria including the matrix effect, carry over, dilution integrity, and has shown reproducible recovery on extraction from plasma. The results of the stability studies were satisfactory, and the method was successfully applied for the analysis of clinical samples. In contrast to the plasma method, the DBS method failed to show linearity and is not suggestive for analysis of the selected antibiotics.
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U2 - 10.7324/JAPS.2025.214611
DO - 10.7324/JAPS.2025.214611
M3 - Article
AN - SCOPUS:105000096845
SN - 2231-3354
VL - 15
SP - 129
EP - 142
JO - Journal of Applied Pharmaceutical Science
JF - Journal of Applied Pharmaceutical Science
IS - 3
ER -