Bioanalytical Method Development and Validation of Acetaminophen in Human Milk Using LC-MS/MS
Abstract
Abstract A UFLC–MS/MS method was developed and validated for the quantification of acetaminophen (paracetamol) in human milk using paracetamol-D7 as the internal standard. Solid phase extraction was used to generate samples (50 µL), which were then separated on a Reprosil Gold column (50 mm × 4.6 mm, 5 µm) and analysed on a triple quadrupole Sciex API 4000 system. The viability of the method was evaluated using human milk from independent donors. The assay had a linear range between 25.082–15,019.284 ng/mL and a r 2 > 0.99. 25.082 ng/mL was the lower limit of quantification (LLOQ), with precision of 3.15% and accuracy of 97.21%. Inter batch and Intra batch Precision (%CV) ranged from 0.13 to 6.23 and 5.43 to 7.46, 2.43 to 7.54 whereas accuracy(% Nominal) varied from 91.66 to 114.45 and 84.24 to 99.06,89.63 to 110.06 roughly during validation tests. The IS normalized matrix factor %CVs were ≤ 15% (LQC 2.89; HQC 0.99) and the mean analyte recovery was 77.37% (%CV 6.27%). There was no evidence of internal interference or carryover, and the signal to noise ratios at LLOQ were high (113.411–163.070). Benchtop, autosampler, freeze-thaw, wet extract, short-term, and long-term stock stability tests all satisfied acceptance requirements. Studies on Matrix effect, Signal to noise ratio and dilution integrity verified dependable functioning under various circumstances. Interconversion between analyte and IS was quite small. For determining the amount of Acetaminophen in human milk, the…
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