Publication | Open Access
Development and Validation of a High Throughput Lc-Ms/Ms Method for Quantitation of Ipilimumab in Human Plasma
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2022
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Analytical Lc-ms/ms MethodologiesEngineeringImmunologyReference StandardGas ChromatographyBioanalysisAnalytical ChemistryBiomarker DiscoveryClinical ChemistryLiquid ChromatographyLaboratory MedicineChromatographyBiochemistryWater QualityChromatographic AnalysisPharmacologyWater AnalysisEnvironmental EngineeringMass SpectrometryHuman PlasmaRetention TimeMedicinePharmacokineticsDrug Analysis
>For the analytical determination of ipilimumab employing cetuximab as a reference standard, a simple, fast, accurate, robust, and repeatable LC-MS/MS methodology was devised. This study investigated current developments in analytical LC-MS/MS methodologies. The Waters symmetry C18 column (150 x 4.6 mm, 3.5) was employed at ambient temperature under isocratic elution. Acetonitrile (ACN) and 0.1% aqueous solution of formic acid were utilized as mobile phase at 1.0-mL per min flow rate. The injection volume was 10 μL, and the operation period was 7 minutes. The overall methodology duration was 7 minutes, with a retention time being 3.124 minutes for Ipilimumab. Validated across a static linearity range of 12.50–100 ng/mL for Ipilimumab with a correlation value of 0.99961. Outcomes for precision, matrix effect, recovery, accuracy, and stability fell within acceptable parameters.