International Journal of Drug Delivery Technology
Volume 14, Issue 2

Bioanalytical Method Development and Validation for Determination of Nirmatrelvir in Human Plasma using LC-MS/MS

Nameera Jabeen1*, M Akiful Haque2

1Department of Pharmaceutical Analysis, Vishnu Institute of Pharmaceutical Education and Research, Medak, Telangana, India.

2Department of Pharmaceutical Analysis, Anurag University, Hyderabad, Telangana, India. 

Received: 15th January, 2024; Revised: 24th March, 2024; Accepted: 18th May, 2024; Available Online: 25th June, 2024 

ABSTRACT

The term “antivirals” has been associated with COVID-19 during the period when the usage of this specific class of medications has increased. Nirmatrelvir, a protease inhibitor, is used to treat mild to moderate COVID-19 symptoms by stopping SARS- COV-2 reproduction. With deucravacitinib serving as the internal standard, liquid chromatography-tandem mass spectroscopy in human plasma was used to provide a quick, simple, innovative, trustworthy, and sensitive approach. Liquid-liquid extraction was used to separate nirmatrelvir and the internal standard. The extracted sample was then run through a chromatographic system with ACE-C18 column (4.6 × 100 mm, 5 µm); and mobile phase with methanol and 2 mM ammonium formate in a ratio of 80:20, and a flow rate of 1.00 mL/min. The system operates for three minutes in multiple reaction monitoring mode at the ABSCIEX API 4000 mass spectrometer using electron spray ionization. Nirmatrelvir ion transitions are 500.10 to 110.10, while deucravacitinib are 426.30 to 358.20. The validation was conducted using a concentration range of 5.00 to 4000 ng/mL, and the results showed that the selectivity, accuracy, precision, linearity, and selectivity were all within the acceptability limits.

Keywords: Nirmatrelvir, Deucravacitinib, Liquid-liquid extraction, Human plasma, methanol, Ammonium formate. International Journal of Drug Delivery Technology (2024); DOI: 10.25258/ijddt.14.2.44

How to cite this article: Jabeen N, Haque MA. Bioanalytical Method Development and Validation for Determination of Nirmatrelvir in Human Plasma using LC-MS/MS. International Journal of Drug Delivery Technology. 2024;14(2):902-906.

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