Paper Title
Stability Indicating Analytical Method Development and Validation for Molnupiravir in Human Plasma
Article Identifiers
Authors
Vaibhav Vilas Narwade , Madhuri D. Game
Keywords
RP-HPLC, Molnupiravir, Method Development, Validation
Abstract
This study presents a robust and validated reverse-phase high-performance liquid chromatography (RP-HPLC) method for the quantification of Molnupiravir, an antiviral drug used in the treatment of COVID-19. The method was developed and optimized using a C18 column with a mobile phase consisting of methanol and sodium acetate buffer. System suitability tests demonstrated the appropriateness of the chromatographic system, ensuring precision, resolution, and peak symmetry. The method exhibited excellent specificity, as evidenced by the matching retention times of standard and test samples. Linearity was confirmed over a concentration range of 15-45 µg/ml, with a correlation coefficient (R²) of 0.9995. Accuracy studies revealed recoveries ranging from 99.81% to 101.91%, indicating the method's reliability. Precision assessments, including intra-day and inter-day variations, demonstrated reproducibility with %RSD values within acceptable limits. Additionally, the method showed adequate sensitivity, with limits of detection (LOD) and quantification (LOQ) of 1.04 µg/ml and 3.17 µg/ml, respectively. Robustness studies indicated that small variations in method parameters did not significantly affect assay results. Stability studies under various stress conditions demonstrated the drug's susceptibility to degradation under acidic conditions while showing stability under other conditions. Overall, the validated RP-HPLC method offers a simple, accurate, and precise means for the routine analysis of Molnupiravir, contributing to the effective management of COVID-19 treatment protocols.
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How To Cite (APA)
Vaibhav Vilas Narwade & Madhuri D. Game (May-2024). Stability Indicating Analytical Method Development and Validation for Molnupiravir in Human Plasma. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 9(5), d739-d748. https://ijnrd.org/papers/IJNRD2405383.pdf
Issue
Volume 9 Issue 5, May-2024
Pages : d739-d748
Other Publication Details
Paper Reg. ID: IJNRD_218945
Published Paper Id: IJNRD2405383
Downloads: 000121981
Research Area: Pharmacy
Country: Hingoli, Maharashtra, India
Published Paper PDF: https://ijnrd.org/papers/IJNRD2405383.pdf
Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2405383
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Journal Name: INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT(IJNRD)
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This work is licensed under a Creative Commons Attribution 4.0 International License and The Open Definition
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