Title:Development and Validation of In-vitro Release Study of Molnupiravir
Capsules by RP-HPLC
Volume: 19
Issue: 7
Author(s): Shipra Singhal, Aman Sharma, Anirudh Malik, Meenakshi Dahiya, Gaurav Pratap Singh Jadaun, Vaishali M. Patil*Shikha Kaushik
Affiliation:
- Department of Pharmaceutical Chemistry, KIET School of Pharmacy, KIET Group of Institutions, Delhi NCR,
Ghaziabad, India
- Faculty of Pharmaceutical
Sciences, UCSI University, Kuala Lumpur, Malaysia
Keywords:
Molnupiravir, SARS-CoV-2, RP-HPLC, validation, ICH guideline, N-4-hydroxycytidine.
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.