ABSTRACT:
A simple precise, rapid accurate and sensitive non-aqueous potentiometric titration method was developed for quantitative determination of molnupiravir from pharmaceutical dosage form. The titration was carried out using standardized 0.1 N perchloric acid. The proposed method was found to be precise with % RSD <1 (n = 6). The method showed strict linearity (r2 > 0.9999) between 10 % to 50 % w/v of 100 mg of drug substance weight. The percentage recovery of molnupiravir in the optimized method was between 99.05 to 99.81 %. The method is also found to be rugged when checked by different analysts and using different lots of reagents and different makes of titrators.
Cite this article:
Rele Rajan V., Tiwatane Prathamesh P.. A Validated Potentiometric Titration Method for Quantitative Determination of Molnupiravir from Pharmaceutical Preparation. Asian Journal of Research in Chemistry. 2022; 15(6):439-2. doi: 10.52711/0974-4150.2022.00077
Cite(Electronic):
Rele Rajan V., Tiwatane Prathamesh P.. A Validated Potentiometric Titration Method for Quantitative Determination of Molnupiravir from Pharmaceutical Preparation. Asian Journal of Research in Chemistry. 2022; 15(6):439-2. doi: 10.52711/0974-4150.2022.00077 Available on: https://ajrconline.org/AbstractView.aspx?PID=2022-15-6-9
REFERENCES:
1. R.C. Group. Lopinavir-ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomized, controlled, open-label, platform trial. Lancet. 396 (10259); 2020 :1345–1352.
2. Chen J, Xia L, Liu L, Xu Q, Ling Y, Huang D, Huang W, Song S, Xu S, Shen Y, Lu H. Antiviral Activity and Safety of Darunavir/Cobicistat for the Treatment of COVID-19. Open Forum Infect Dis. 7 (7; 2020; 241
3. Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, Hohmann E, Chu HY, Luetkemeyer A, Kline S, Lopez de Castilla D, et al. Remdesivir for the Treatment of Covid-19 - Final Report. The New England journal of medicine. 383 (19); 2020; 1813–1826.
4. Toots M, Yoon J-J, Cox RM, Hart M, Sticher ZM, Makhsous N, Plesker R, Barrena AH, Reddy PG, Mitchell DG, Shean RC, et al. Characterization of orally efficacious influenza drug with high resistance barrier in ferrets and human airway epithelia. Sci Transl Med. 11 (515); 2019; 5866.
5. Sheahan TP, Sims AC, Zhou S, Graham RL, Pruijssers AJ, Agostini ML, Leist SR, Schafer A, Dinnon KH 3rd, Stevens LJ, Chappell JD, et al. An orally bioavailable broad-spectrum antiviral inhibits SARS-CoV-2 in human airway epithelial cell cultures and multiple coronaviruses in mice. Sci Transl Med.12 (541); 2020
6. Painter GR, Bowen RA, Bluemling GR, DeBergh J, Edpuganti V, Gruddanti PR, Guthrie DB, Hager M, Kuiper DL, Lockwood MA, Mitchell DG, et al. The prophylactic and therapeutic activity of a broadly active ribonucleoside analog in a murine model of intranasal venezuelan equine encephalitis virus infection. Antiviral Res.; 171; 2019: 104597.
7. Painter WP, Holman W, Bush JA, Almazedi F, Malik H, Eraut NCJE, Morin MJ, Szewczyk LJ, Painter GR. Human Safety, Tolerability, and Pharmacokinetics of a Novel Broad-Spectrum Oral Antiviral Compound, Molnupiravir, with Activity Against SARS-CoV-2. medRxiv.12.10; 2020:.20235747.
8. Amara et al. J Pharm Biomed Anal. 2021 9.
9. Rosenke K, Hansen F, Schwarz B, Feldmann F, Haddock E, Rosenke R, Meade-White K, Okumura A, Leventhal S, Hawman DW, Ricotta E, et al. Orally delivered MK-4482 inhibits SARS-CoV-2 replication in the Syrian hamster model. Res Sq. .3; 2020:86289.
10. Alieu Amaraa, Sujan Dilly Penchalaa, Laura Elsea, Colin Haleb, Richard Fitz Geraldb, Lauren Walkerb, Rebecca Lyonsb, Tom Fletcherc, Saye Khoo, The development and validation of a novel LC-MS/MS method for the simultaneous quantification of Molnupiravir and its metabolite ß-d-N4-hydroxycytidine in human plasma and saliva, J Pharm Biomed Anal. 206; 2021: 114356. doi:10.1016/j.jpba.2021.11435628.
11. Tuba Reçber, Selin Seda Timur, Sevilay Erdo˘gan Kablan , Fatma Yalçın, Tutku Ceren Karabulut, R. Neslihan Gürsoy, Hakan Ero˘glu , Sedef Kır, A stability indicating RP-HPLC method for determination of the COVID-19 drug molnupiravir applied using nanoformulations in permeability studies, Journal of pharmaceutical and biomedical analysis, 214; (2022): 114693.
12. Rele Rajan V. Tiwatane Prathamesh P. Determination of Molnupiravir by Extractive Colorimetric Method from Pharmaceutical Dosage Form, Asian J. Research Chem. 15(4);256-258: 2022; DOI: 10.52711/0974-4150.2022.00046
13. Rele Rajan V. Tiwatane Prathamesh P. A Validated Potentiometric Titration Method for Quantitative Determination of Favipiravir from Pharmaceutical Preparation, Asian J. Research Chem.,15(1); 2022:49-51. DOI: 10.52711/0974-4150.2022.00007.