Author(s):
Vaishnavi Bhau Thorat, Aditi Vitthal Sawant, Nanduri Sri Sesha Sai Swaroop, Sunita Gagare, Ashish Jain
Email(s):
vaishnavithorat1206@gmail.com
DOI:
10.52711/0974-360X.2026.00064
Address:
Vaishnavi Bhau Thorat*, Aditi Vitthal Sawant, Nanduri Sri Sesha Sai Swaroop, Sunita Gagare, Ashish Jain
Department of Quality Assurance, Shri D.D Vispute College of Pharmacy and Research Center, New Panvel, 410206.
*Corresponding Author
Published In:
Volume - 19,
Issue - 1,
Year - 2026
ABSTRACT:
An antiviral medication called Nimatrelvir functions as a protease inhibitor similar to 3C. Ritonavir and nimatrelvir are combined to treat COVID-19. The rapid, simple and precise analysis methods for Nirmatrelvir are needed. In order to estimate Nirmatrelvir, we developed a UV-visible spectroscopic and RP-HPLC approach. The conditions employed for UV-visible spectroscopic include the linearity ranging from 10-60µg/ml which is the same in RP-HPLC as well. The coefficient of determination was observed which were 0.9996 and 0.9997 respectively for UV-visible spectroscopy and RP-HPLC. An Inertsil ODS 3V column (250x4.6mm, 5µ), a mobile phase consisting of a 55:45 v/v mixture of acetonitrile and water, a column oven temperature set at 25°C, a flow rate of 1.0ml/min, and a 10minute run duration in isocratic elution mode are typical RP-HPLC characteristics. The forced degradation tests in powdered and solutions form were carried out. The drug showed specificity as there was no interference of impurities in the estimation of Nirmatrelvir. The peak purity of Nirmatrelvir was then assessed by using a high-performance liquid chromatography photodiode array detector (PDA) on all degradation samples. The developed approach was determined to be a straightforward, innovative, methodical, and economic stability-indicating approach after it underwent complete validation in line with ICH (International Council of Harmonisation) principles.
Cite this article:
Vaishnavi Bhau Thorat, Aditi Vitthal Sawant, Nanduri Sri Sesha Sai Swaroop, Sunita Gagare, Ashish Jain. Analytical Method Development and Validation by Using UV-visible spectrophotometry and the RP-HPLC for the Estimation of Nirmatrelvir in Bulk and Dosage form as well as Stability Indicating RP-HPLC in bulk. Research Journal of Pharmacy and Technology. 2026;19(1):439-5. doi: 10.52711/0974-360X.2026.00064
Cite(Electronic):
Vaishnavi Bhau Thorat, Aditi Vitthal Sawant, Nanduri Sri Sesha Sai Swaroop, Sunita Gagare, Ashish Jain. Analytical Method Development and Validation by Using UV-visible spectrophotometry and the RP-HPLC for the Estimation of Nirmatrelvir in Bulk and Dosage form as well as Stability Indicating RP-HPLC in bulk. Research Journal of Pharmacy and Technology. 2026;19(1):439-5. doi: 10.52711/0974-360X.2026.00064 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2026-19-1-64
REFERENCES:
1. Rai DK, Yurgelonis I, McMonagle P, Rothan HA, Hao L, Gribenko A, Titova E, Kreiswirth B, White KM, Zhu Y, Anderson AS. Nirmatrelvir, an orally active Mpro inhibitor, is a potent inhibitor of SARS-CoV-2 Variants of Concern. BioRxiv. 2022; Jan 19: 2022-01. doi: https://doi.org/10.1101/2022.01.17.476644.
2. Ilayaraja P, Manivannan M, Parthiban P. Novel stability indicating HPLC method for the quantification of Nirmatrelvir in bulk drugs. Microchemical Journal. 2024; 196: 109707. doi: https://doi.org/10.1016/j.microc.2023.109707.
3. Reyes VM, Martínez O, Hernández GF. National center for biotechnology information. Plant Breeding. Universidad Autonoma Agraria Antonio Narro, Calzada Antonio Narro. 1923.
4. Sisubalan AP, Manickam C, Ramaswamy V, Natesan S. analytical method development and validation for simultaneous estimation of nirmatrelvir and ritonavir in pharmaceutical dosage form by RP-HPLC. 2024. doi: 10.20959/wjpr20249-32174.
5. European Medicines Agency. "ICH Guideline Q2 (R2) on Validation of Analytical Procedures." (2022).
6. Alegete P, Byreddy S. Development of a novel quality by design–enabled stability‐indicating HPLC method and its validation for the quantification of nirmatrelvir in bulk and pharmaceutical dosage forms. Biomedical Chromatography. 2024; 38(3): 5812. doi: 10.1002/bmc.5812.
7. Imam MS, Batubara AS, Gamal M, Abdelazim AH, Almrasy AA, Ramzy S. Adjusted green HPLC determination of nirmatrelvir and ritonavir in the new FDA approved co-packaged pharmaceutical dosage using supported computational calculations. Scientific reports. 2023; 13(1): 137. doi: https://doi.org/10.1038/s41598-022-26944-y.
8. Sutar SV, Yeligar VC, Patil SS. Stability Indicating Forced Degradation Studies. Research Journal of Pharmacy and Technology. 2019; 12(1): 429-33. doi. http://dx.doi.org/10.5958/0974-360X.2019.00078.7.
9. Sonia K, Nappinnai M, Panneerselvam P. Stability indicating method development and Validation of Telmisartan and Ramipril by UV Spectrophotometry. Research Journal of Pharmacy and Technology. 2018; 11(7): 3087-90. doi: 10.5958/0974-360X.2018.00567.
10. Naga Venkata Indira Devi Jajula, A. Krishnamanjari Pawar. Development and Validation of Stability Indicating Method for Simultaneous Estimation of Paritaprevir, Ombitasvir, and Ritonavir in Tablet Dosage Form. Research Journal of Pharmacy and Technology 2023; 16(5): 2306-0. doi: 10.52711/0974-360X.2023.00379
11. M. R. Ghante, R. B. Tangade, S. D. Sawant, P. D. Kulkarni , V. K. Bhusari. Development and Validation of stability indicating RP-HPLC method for the estimation of Ertugliflozin by forced degradation studies. Research Journal of Pharmacy and Technology. 2022; 15(11): 4945-9. doi: 10.52711/0974-360X.2022.00831
12. Thoddi P, Gautam GK, BH C. Stability indicating validated RP-HPLC method for Simultaneous estimation of Elbasvir and Grazopravir in Bulk and Pharmaceutical Dosage form. Research Journal of Pharmacy and Technology. 2020; 13(2): 950-5. doi: 10.5958/0974-360X.2020.00179.1
13. Manasa M, Aanandhi VM. Stability indicating method development and validation of semaglutide by RP-HPLC in pharmaceutical substance and pharmaceutical product. Research Journal Of Pharmacy And Technology. 2021; 14(3): 1385-9. doi: 10.5958/0974-360X.2021.00247.X
14. Gopal Prasad Agrawal. Validated Stability Indicating Method for Determination of Indapamide in Pharmaceutical Formulation. Research Journal of Pharmacy and Technology. 2021; 14(6): 3347-2. doi: 10.52711/0974-360X.2021.00582
15. Patel K, Verriboina SK, Vasantharaju SG. Stability indicating assay method development and validation of simultaneous estimation of chlorzoxazone, diclofenac sodium and paracetamol in bulk drug and tablet by RP-HPLC. Research Journal of Pharmacy and Technology. 2021; 14(9): 5024-8. doi: 10.52711/0974-360X.2021.00876
16. Kishore Konam, Somasekhar Reddy Kanala. A Stability Indicating Method Development and Validation for The Simultaneous Estimation of Emtricitabine, Tenofovir Alafenamide and Doultegravir in Pharmaceutical Formulation by Ultra Performance Liquid Chromatography. Research Journal of Pharmacy and Technology. 2021; 14(11): 6017-4. doi: 10.52711/0974-360X.2021.01046
17. A. Indira, N. Y. Sreedhar, D. Balakrishna. A Stability Indicating Method Development of Lopinavir and Rotinavir in Combined Tablet Dosage Forms by RP-HPLC. Research Journal of Pharmacy and Technology. 2022; 15(2): 661-4. doi: 10.52711/0974-360X.2022.00109