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

GOPE EDWARD RAJU; SRIKANTH POTTENDLA; SUNEETHA YAPARTHI

doi:10.22159/ajpcr.2025v18i3.53760

Authors

GOPE EDWARD RAJU Department of Pharmaceutical Analysis, Dr. Samuel George Institute of Pharmaceutical Sciences, Markapur, Acharya Nagarjuna University, Guntur, Andhra Pradesh, India https://orcid.org/0009-0008-3260-7997
SRIKANTH POTTENDLA Department of Pharmacology, Dr. Samuel George Institute of Pharmaceutical Sciences, Markapur, Andhra Pradesh, India
SUNEETHA YAPARTHI Department of Pharmaceutical Chemistry, Dr. Samuel George Institute of Pharmaceutical Sciences, Markapur, Andhra Pradesh, India.

DOI:

https://doi.org/10.22159/ajpcr.2025v18i3.53760

Keywords:

Ensitrelvir, Remdesivir, Liquid chromatography-tandem mass spectrometry, USFDA guidelines, Rat plasma

Abstract

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.

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