Box-Behnken Design Assisted AQbD Approach for the Optimization and Quality Assessment of Ensitrelvir in Bulk and Dosage forms by RP-HPLC DOI Open Access
B Sivagami, M. Dinesh,

Pavan Kumar

et al.

Biosciences Biotechnology Research Asia, Journal Year: 2024, Volume and Issue: 21(4), P. 1593 - 1604

Published: Dec. 20, 2024

ABSTRACT: Ensitrelvir, is an oral SARS-CoV-2 3CL protease inhibitor that was approved in Japan to treat infections. This paper describes the AQbD approach and Box Behnken Design assisted development of a HPLC method its validation for Ensitrelvir bulk dosage form. The three independent variables RP-HPLC were flow rate, organic ratio mobile phase runtime responses retention time tailing factor taken as dependent variables. study utilized PLATSIL C18-EP column (4.6 x 250mm, 5µm) chromatographic conditions optimized using Acetonitrile: Triethylamine pH: 4 (60:40 mL) phase, 1 mL/min rate with Rt 9.609 min, at λ max 228 nm. devised technique found be linear serial dilution 10–50 μg/ml (r2) 0.991. (TF) theoretical plates (N) 1.28 4883 results indicated system suitability test, respectively. precision Intraday Interday determined % RSD observed 1.6 0.9 %. robustness values below 2%. No other coeluting peaks peak, according peak purity data. According ICH specifications, parameters within permissible range.

Language: Английский

Impact of patient’s financial burden of COVID-19 treatment on antiviral prescription rates and clinical and economic outcomes DOI Creative Commons

Mitsuhiro Nagano,

Sachiko Hyokai,

Kanae Togo

et al.

Expert Review of Pharmacoeconomics & Outcomes Research, Journal Year: 2024, Volume and Issue: unknown

Published: Sept. 30, 2024

In Japan, medical expenses for COVID-19 treatment transitioned from full public funding support to out-of-pocket (OOP) payment by patients plus partial in October 2023, and fully ended March 2024. This study evaluated the clinical economic impacts of initiating OOP payments.

Language: Английский

Citations

0
Synthesis and evaluation of N-arylindazole-3-carboxamide derivatives as novel antiviral agents against SARS-CoV-2 DOI Creative Commons
Jeong Yong Lee, Sangeun Jeon,

Jung‐Eun Cho

et al.

Bioorganic & Medicinal Chemistry Letters, Journal Year: 2024, Volume and Issue: 114, P. 130015 - 130015

Published: Nov. 1, 2024

Language: Английский

Citations

0
Box-Behnken Design Assisted AQbD Approach for the Optimization and Quality Assessment of Ensitrelvir in Bulk and Dosage forms by RP-HPLC DOI Open Access
B Sivagami, M. Dinesh,

Pavan Kumar

et al.

Biosciences Biotechnology Research Asia, Journal Year: 2024, Volume and Issue: 21(4), P. 1593 - 1604

Published: Dec. 20, 2024

ABSTRACT: Ensitrelvir, is an oral SARS-CoV-2 3CL protease inhibitor that was approved in Japan to treat infections. This paper describes the AQbD approach and Box Behnken Design assisted development of a HPLC method its validation for Ensitrelvir bulk dosage form. The three independent variables RP-HPLC were flow rate, organic ratio mobile phase runtime responses retention time tailing factor taken as dependent variables. study utilized PLATSIL C18-EP column (4.6 x 250mm, 5µm) chromatographic conditions optimized using Acetonitrile: Triethylamine pH: 4 (60:40 mL) phase, 1 mL/min rate with Rt 9.609 min, at λ max 228 nm. devised technique found be linear serial dilution 10–50 μg/ml (r2) 0.991. (TF) theoretical plates (N) 1.28 4883 results indicated system suitability test, respectively. precision Intraday Interday determined % RSD observed 1.6 0.9 %. robustness values below 2%. No other coeluting peaks peak, according peak purity data. According ICH specifications, parameters within permissible range.

Language: Английский

Citations

0