Analytical Method Development and Validation For Rp-HPLC Based Nirmatrelvir Estimation in Bulk and Dosage Form

DOI

10.2991/978-94-6463-813-4_33How to use a DOI?

Keywords

‘Nirmatrelvir’; HPLC; Validation; Limit of detection

Abstract

Nirmatrelvir is an antiviral medication used in the treatment of COVID-19. It functions by inhibiting a specific protease, a protein essential for viral replication. Blocking this protease disrupts the virus's ability to multiply and continue its infectious cycle. Due to the clinical importance of Nirmatrelvir, It was essential to create a straightforward, economical, and time-efficient technique for estimating it. The current effort aimed to design and confirm a rapid, reliable, and highly precise Reverse Phase-High Performance Liquid Chromatographic procedure for estimating Nirmatrelvir. The RP-HPLC approach was carried out using a Shimadzu LC-20AD system configured with a UV/VIS detector. At a precise retention time of 6.143 min, Nirmatrelvir was seen. The method was validated in line with ICH Q2 (R1) guidelines estimating key parameters such as accuracy, precision, linearity, detection limit (LOD), and quantitation limit (LOQ). (ICH, 2005) The LOD &LOQ values for Nirmatrelvir were successfully determined as 0.378µg/ml and 1.146 µg/ml. A linear calibration curve was obtained across the 10–60 µg/ml range with a strong correlation coefficient R² = 0.9984. Accuracy was confirmed at 99.6%, while precision studies yielded a relative standard deviation (%RSD) below 2% over six replicates, confirming excellent method reproducibility. The developed method also proved effective in confirming the chemical structure of newly synthesized Nirmatrelvir. An efficient, economical, and robust ‘RP-HPLC’ technique was optimized and verified in compliance with ICH requirements for the quantitative estimation of Nirmatrelvir. The optimized process has shown consistent reliability for regular quality assessment and stability testing of Nirmatrelvir in various drug products.

Copyright

© 2025 The Author(s)

Open Access

Open Access This chapter is licensed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license and indicate if changes were made.

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TY  - CONF
AU  - Raja Sundararajan
AU  - Kiran Kumar Ganta
PY  - 2025
DA  - 2025/08/13
TI  - Analytical Method Development and Validation For Rp-HPLC Based Nirmatrelvir Estimation in Bulk and Dosage Form
BT  - Proceedings of the International symposium on Sustainable Drug Design and Nanoparticle development: Quantum and Computational Perspectives (SDDNDQCP 2025)
PB  - Atlantis Press
SP  - 441
EP  - 456
SN  - 2468-5739
UR  - https://doi.org/10.2991/978-94-6463-813-4_33
DO  - 10.2991/978-94-6463-813-4_33
ID  - Sundararajan2025
ER  -