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Method Development and Validation for the Analysis of Apalutamide in Human Plasma by LC–MS/MS

Introduction: Highly specific, selective and accurate liquid chromatography/tandem mass spectrometry (LC–MS/MS) technique was desirable for the assessment of apalutamide in human plasma. Aims: To develop and validate LC-MS/MS method for the analysis of apalutamide in human plasma. Methodology: Drug and internal standard were extracted utilizing liquid–liquid extraction was performed using ethyl acetate. Reversed phase high performace liquid chromatography (RP-HPLC) was carried out using Inertsil (50×4.6 mm i.d., 5 μm) C18 analytical column with a simple isocratic mobile phase composed of 0.1% formic acid and acetonitrile, (20:80, v/v). Detection was executed on a triple quadrupole mass spectrometer retaining electrospray ionization method, operating in multiple reaction monitoring (MRM), with the transitions of m/z 478.09→ 447.05, m/z 445.14 → 267.12 for apalutamide, canagliflozin, respectively, in the positive ionization mode. The linearity was processed a concentration range of 300–12000 ng/mL for the analyte. Results: The method was validated in accordance with the FDA guidelines for bioanalytical method. All obtained recoveries were higher than 93.0% while the accuracy was in the range of −4.32 to 2.45% of relative error and the relative standard deviation was below 4.21% for all investigated drugs by the proposed method. Conclusion: The validated method has highly sensitive and nice recoveries values from plasma, utilized for the bioequivalence and pharmacokinetic studies.