Development and validation of molnupiravir assessment in bulk powder and pharmaceutical formulation by the RP-HPLC-UV method.

Autor: Annadi AM; Chemistry Department, Faculty of Science, Ain Shams University Abbassia Cairo 11566 Egypt mohd_mostafa@sci.asu.edu.eg., El Zahar NM; Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Ain Shams University, Organization of African Unity Street Abbassia Cairo 11566 Egypt.; Medicinal Chemistry Department, Faculty of Pharmacy, King Salman International University Ras-Sedr, South Sinai Egypt., El-Din A Abdel-Sattar N; Chemistry Department, Faculty of Science, Ain Shams University Abbassia Cairo 11566 Egypt mohd_mostafa@sci.asu.edu.eg., Mohamed EH; Pharmaceutical Chemistry Department, Faculty of Pharmacy, The British University in Egypt ElSherouk City Cairo Egypt., Mahmoud SA; Physics Department, Faculty of Science, Northern Border University Arar Saudi Arabia samahmoud2002@yahoo.com., Attia MS; Chemistry Department, Faculty of Science, Ain Shams University Abbassia Cairo 11566 Egypt mohd_mostafa@sci.asu.edu.eg.
Jazyk: angličtina
Zdroj: RSC advances [RSC Adv] 2022 Nov 30; Vol. 12 (53), pp. 34512-34519. Date of Electronic Publication: 2022 Nov 30 (Print Publication: 2022).
DOI: 10.1039/d2ra05066h
Abstrakt: An accurate, sensitive and selective RP-HPLC-UV method has been established for the estimation of Molnupiravir (MOL) in pure bulk powder and pharmaceutical formulation. Separation was achieved on an Inertsil C 18 column (150.0 mm × 4.6 mm, 5.0 μm), using a mobile phase of 20 mM phosphate buffer pH 2.5 : acetonitrile (80 : 20, v/v%) in isocratic mode with a flow rate of 1.0 mL min -1 . The λ max of MOL prepared in the chosen diluent (ethanol : water in equal proportions) was found to be 230.0 nm. The constructed calibration curve was found to be linear in the concentration range of 0.2-80.0 μg mL -1 . The recovery% of MOL using the proposed method was 100.29%. The limit of detection (LOD) and limit of quantification (LOQ) were 0.04 μg mL -1 and 0.12 μg mL -1 , respectively. No significant interference was detected in the presence of the common pharmaceutical formulation excipients. The method was validated following the ICH recommendations. All the obtained results were statistically compared with those using reported methods and there were no significant differences. The method developed in this work was successfully employed for the assessment of MOL in bulk powder and pharmaceutical formulation.
Competing Interests: The authors declare no conflict of interest.
(This journal is © The Royal Society of Chemistry.)
Databáze: MEDLINE
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