UPLC Estimate of Sofosbuvir and Ledipasvir Utilizing Greenness Tool in Conjunction With an Analytical Quality by Design

ABSTRACT Ledipasvir in combination with sofosbuvir approved by regulatory bodies used to treat chronic hepatitis C. The present work investigates the design and development of a new, quick, green, and selective UPLC (ultra‐performance liquid chromatography) approach to concurrently quantify sofosbuv...

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Bibliographic Details
Published in:Biomedical chromatography 2025-01, Vol.39 (1), p.e6047-n/a
Main Authors: Bairam, Ravinder, Mahesh, Kemmasaram, Tatapudi, Hemant Kumar, Thoom, Shruthi
Format: Article
Language:English
Subjects:
Benzimidazoles - analysis
Benzimidazoles - chemistry
Chromatography, High Pressure Liquid - methods
Fluorenes - analysis
Fluorenes - chemistry
green analytical method
Green Chemistry Technology - methods
ledipasvir
Limit of Detection
Linear Models
quality by design
Reproducibility of Results
sofosbuvir
Sofosbuvir - analysis
Sofosbuvir - chemistry
UPLC
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Summary:ABSTRACT Ledipasvir in combination with sofosbuvir approved by regulatory bodies used to treat chronic hepatitis C. The present work investigates the design and development of a new, quick, green, and selective UPLC (ultra‐performance liquid chromatography) approach to concurrently quantify sofosbuvir and ledipasvir. Optimization with Box–Behnken design paired the green analytical method and quality by design‐based risk assessment. A mobile phase of 65%:35% ethanol by volume and phosphate buffer (15 mM; pH 3.0) was used, with a flow rate of 0.28 mL per minute, to achieve the best chromatographic separation. With linearities ranging from 20 to 100, 4.5–22.5 μg/mL, and R2 values of 0.9999 and 0.9997, respectively, the established UPLC‐PDA technique proved sensitive and specific for sofosbuvir and ledipasvir. The stability‐indicating test findings demonstrate the degradation under the relevant stress conditions. The most environmentally friendly results were found when the level of environmental sustainability was evaluated using four advanced metrics: GAPI, AES, AMGS, and AGREE. Based on the findings, we came to the conclusion that the UPLC technique that was developed would be effective for the concurrent analysis of sofosbuvir and ledipasvir in tablet medication.
ISSN:0269-3879
1099-0801
1099-0801
DOI:10.1002/bmc.6047