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A stability indicating RP-HPLC method for determination of the COVID-19 drug molnupiravir applied using nanoformulations in permeability studies.
Reçber, Tuba; Timur, Selin Seda; Erdogan Kablan, Sevilay; Yalçin, Fatma; Karabulut, Tutku Ceren; Neslihan Gürsoy, R; Eroglu, Hakan; Kir, Sedef; Nemutlu, Emirhan.
  • Reçber T; Hacettepe University, Faculty of Pharmacy, Department of Analytical Chemistry, 06100 Sihhiye, Ankara, Turkey.
  • Timur SS; Hacettepe University, Faculty of Pharmacy, Department of Pharmaceutical Technology, 06100 Sihhiye, Ankara, Turkey.
  • Erdogan Kablan S; Hacettepe University, Faculty of Pharmacy, Department of Analytical Chemistry, 06100 Sihhiye, Ankara, Turkey.
  • Yalçin F; Tobio Novelfarma Drug Industry and Trade Limited Company, 34768 Ümraniye, Istanbul, Turkey.
  • Karabulut TC; Tobio Novelfarma Drug Industry and Trade Limited Company, 34768 Ümraniye, Istanbul, Turkey; Ankara University, Faculty of Pharmacy, Department of Analytical Chemistry, 06100 Tandogan, Ankara, Turkey.
  • Neslihan Gürsoy R; Hacettepe University, Faculty of Pharmacy, Department of Pharmaceutical Technology, 06100 Sihhiye, Ankara, Turkey.
  • Eroglu H; Hacettepe University, Faculty of Pharmacy, Department of Pharmaceutical Technology, 06100 Sihhiye, Ankara, Turkey.
  • Kir S; Hacettepe University, Faculty of Pharmacy, Department of Analytical Chemistry, 06100 Sihhiye, Ankara, Turkey.
  • Nemutlu E; Hacettepe University, Faculty of Pharmacy, Department of Analytical Chemistry, 06100 Sihhiye, Ankara, Turkey. Electronic address: enemutlu@hacettepe.edu.tr.
J Pharm Biomed Anal ; 214: 114693, 2022 May 30.
Article in English | MEDLINE | ID: covidwho-1701941
ABSTRACT
Antiviral drugs have gained much more attention in recent years due to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection and many drug candidates are currently under investigation in order to end pandemic. Molnupiravir, a prodrug of the synthetic nucleoside derivative N4-hydroxycytidine, is one of the promising candidates for SARS-CoV-2 treatment. In this study, a RP-HPLC method was developed for the determination of Molnupiravir and applied for in vitro permeability studies of self-emulsifying drug delivery system (SEDDS) formulations using Caco-2 cell line. Discovery® HS C18 Column (75 ×4.6 mm, 3 µm) was used at 30 °C. Isocratic elution was performed with ACNwater (2080 v/v) mixture. The flow rate was 0.5 mL/min and UV detection was at 240 nm. Molnupiravir eluted within 5 min. Molnupiravir was exposed to thermal, photolytic, hydrolytic, and oxidative stress conditions. Peak homogeneity data of Molnupiravir in the stressed samples peak obtained using photodiode array detector, in the stressed sample chromatograms, demonstrated the specificity of the method for their estimation in presence of degradants. The developed method was validated according to the International Council for Harmonisation (ICH) guidelines and found to be linear within the range 0.1-60.0 µg/mL. The method was simple, rapid, selective, sensitive, accurate, precise, robust and rugged. Thus, it was applied successfully for permeability quantitation of Molnupiravir in nanoformulations. The apparent permeability of Molnupiravir in SEDDS formulations, which have droplet size under 350 nm, was calculated as 3.20 ± 0.44 × 10-6 cm/s.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Drug Treatment Type of study: Diagnostic study / Prognostic study Limits: Humans Language: English Journal: J Pharm Biomed Anal Year: 2022 Document Type: Article Affiliation country: J.jpba.2022.114693

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Drug Treatment Type of study: Diagnostic study / Prognostic study Limits: Humans Language: English Journal: J Pharm Biomed Anal Year: 2022 Document Type: Article Affiliation country: J.jpba.2022.114693