Quantitative determination of carvedilol in human plasma by high-performance liquid chromatography using fluorescence detection
Year: 2024
Type: article
Abstract: Background: Carvedilol is a pharmaceutical substance listed in the “Regulatory requirements of bioequivalence study reports for generic drugs containing APIs upon applying for marketing authorization”. Therefore, a simple method for quantifying carvedilol in human plasma is desirable. Objectives: This study aims to develop an HPLC method for quantitation of carvedilol in human plasma. Materials and method: The blank human plasma was spiked with carvedilol standard. After optimizing the process, the method was validated according to the guidelines for the validation of bioanalytical methods of US-FDA and EMA. Results: Carvedilol and metoprolol as internal standard were extracted from plasma by protein precipitation technique with acetonitrile. Plasma samples were eluted through a Zorbax Eclipse XDB-C8 (5 μm; 4.6 x 150 mm) column with an isocratic mobile phase consisting of 0.1% trifluoroacetic acid in water, acetonitrile, and methanol (60:20:20; v/v/v). The analytical method met the criteria according to the US-FDA and EMA guidelines for the bioanalytical method validation. Conclusion: The method can be applied to determine carvedilol in biological fluid for pharmacokinetic research and bioequivalence assessment.
Source: Tạp chí Y Dược Huế
Authors: Dang Thuy Anh Nguyen, Huu Tien Nguyen
Institutions: Hue University, Huế University of Medicine and Pharmacy
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: hybrid
Funder: Đại học Huế
OpenAlex ID: W4408580224