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.
Chaudhari BB, Lewis LE, Mallayasamy S, Gupta A, Saha M, Kunkalienkar S, Moorkoth S. 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. J Appl Pharm Sci. 2024. Online First. http://doi.org/10.7324/JAPS.2025.214611
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