Stability Indicating Analytical Method Development and Validation for Molnupiravir in Human Plasma

Stability Indicating Analytical Method Development and Validation for Molnupiravir in Human Plasma

Registration ID: IJNRD_218945

Published ID: IJNRD2405383

DOI: Click Here to Get

Vaibhav Vilas Narwade , Madhuri D. Game

RP-HPLC, Molnupiravir, Method Development, Validation

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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"Stability Indicating Analytical Method Development and Validation for Molnupiravir in Human Plasma", IJNRD - INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT (www.IJNRD.org), ISSN:2456-4184, Vol.9, Issue 5, page no.d739-d748, May-2024, Available :https://ijnrd.org/papers/IJNRD2405383.pdf

Volume 9 Issue 5, May-2024

Pages : d739-d748

Paper Reg. ID: IJNRD_218945

Published Paper Id: IJNRD2405383

Downloads: 000121139

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

Journal Name: INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT(IJNRD)

ISSN: 2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar | ESTD YEAR: 2016

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

Publisher: IJNRD (IJ Publication) Janvi Wave

This work is licensed under a Creative Commons Attribution 4.0 International License and The Open Definition

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