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Current Pharmaceutical Analysis

Author(s): Shipra Singhal, Aman Sharma, Anirudh Malik, Meenakshi Dahiya, Gaurav Pratap Singh Jadaun, Vaishali M. Patil* and Shikha Kaushik

DOI: 10.2174/1573412919666230821102105

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Development and Validation of In-vitro Release Study of Molnupiravir Capsules by RP-HPLC

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Abstract

Introduction: The coronavirus disease-2019 (COVID-19) outbreak all over the world has led researchers to strive to develop treatment and preventive measures to control its progression.

Methods: Molnupiravir, a prodrug of the synthetic nucleoside derivative N-4-hydroxycytidine was found to be a promising candidate against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).

Results: It could significantly reduce the risk of hospitalization and mortality among patients with positive SARS-CoV-2 reports. In this study, an RP-HPLC method with UV detection was developed to determine its dissolution and release in the capsule dosage form. The developed method was validated as per International Council for Harmonization (ICH) guidelines.

Conclusion: The method was evaluated and validated for its applicability using various parameters. It was found to be a simple, rapid, selective, sensitive, accurate, precise, robust and rugged method.

Keywords: Molnupiravir, SARS-CoV-2, RP-HPLC, validation, ICH guideline, N-4-hydroxycytidine.

Graphical Abstract

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