Method Development and Validation of a Specific Stability Indicating RP-HPLC Method for Molnupiravir API
Gundapaneni Ravi Kumar *
Department of Analytical Chemistry, GITAM Institute of Sciences, Gandhi Institute of Technology and Management (Deemed to be University), Visakhapatnam, Andhra pradesh-530045, India.
Borra Suman Babu
Department of Analytical Chemistry, GITAM Institute of Sciences, Gandhi Institute of Technology and Management (Deemed to be University), Visakhapatnam, Andhra pradesh-530045, India.
Rayala Rama Rao
Department of Analytical Chemistry, GITAM Institute of Sciences, Gandhi Institute of Technology and Management (Deemed to be University), Visakhapatnam, Andhra pradesh-530045, India.
Vadde Megha Vardhan
Department of Analytical Chemistry, GITAM Institute of Sciences, Gandhi Institute of Technology and Management (Deemed to be University), Visakhapatnam, Andhra pradesh-530045, India.
V. D. N. Kumar Abbaraju
Department of Analytical Chemistry, GITAM Institute of Sciences, Gandhi Institute of Technology and Management (Deemed to be University), Visakhapatnam, Andhra pradesh-530045, India.
*Author to whom correspondence should be addressed.
Abstract
A simple, accurate, isocratic stability indicating RP‐HPLC method was developed for the determination of Molnupiravir in bulk drug. This RP-HPLC was achieved on “Waters 2695 using an Agilent Zorbax Eclipse C18 (250 mm × 4.6 mm × 5 µm)” column with the mobile phase consisting of 30 mM, ammonium phosphate monobasic and Methanol in the ratio of 47:53 %v/v. The stress testing of Molnupiravir was carried out under acidic, alkaline, oxidative, thermal, and photolytic conditions and formed degradation products were well resolved from Molnupiravir API (active pharmaceutical ingredient). The suggested approach was validated according to ICH (International Council on Harmonisation) principles, and all of the validation parameters' findings were within acceptable limits. The method was proven to be appropriate for quality control of Molnupiravir in bulk and pharmaceutical dose forms, as well as stability testing.
Keywords: Assay, stress studies, validation, molnupiravir