BIOANALYTICAL APPROACH TO ENSITRELVIR ESTIMATION USING LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY AND ITS APPLICATION TO PHARMACEUTICAL RESEARCH

Objective: For the bioanalytical approach of ensitrelvir, a liquid chromatography-tandem mass spectrometry (LC-MS/MS) methodology was developed. This technique is simple to use, rapid, exact, active, and repeatable, and it uses remdesivir as an internal standard. Methods: A phenyl column (250×4.6 mm, 5μ) and an organic mobile phase consisting of 0.1% trifluoroacetic acid and acetonitrile in a 50:50 v/v ratio are used in this article to summarize the latest advancements in bioanalytical LC-MS/MS procedures. Results: An excellent linear concentration range from 3 ng/mL to 120 ng/mL was analyzed for ensitrelvir within 5 min (r2 = 0.9998±0.005). It was determined that the outcomes for accuracy, precision, recovery, matrix effect, and stability were all within acceptable ranges. Conclusion: The application successfully applies all the required criteria for pharmacokinetic investigations in rats, including system appropriateness, specificity, linearity, and accuracy, in accordance with US Food and Drug Administration requirements.