Abstract
A bioanalytical method was developed and validated for digoxin. The method was extremely sensitive and without adduct formation by ultra-performance liquid chromatography coupled with electro-spray ionization-tandem mass spectrometry. Internal standard was used as digoxin-d3. The chromatographic optimization was achieved by using an analytical column Kinetex biphenyl C18 and a mobile phase containing 1 mM NH4HCO2 in methanol in a binary gradient mode. The solid phase extraction technique was used for the extraction and cleaning of the analyte from plasma. Multiple reaction monitoring in positive polarity was applied for the quantification of digoxin. The analyzed concentrations ranged from 20 to 4000 pg/ml of digoxin which was used to plot a calibration curve; a linear regression was detected in the range of 0.9955 to 0.9992. The inter-day precision was found in the range of 2.76 to 8.33 for quality control samples. This validated method by using UHPLC-MS/MS can be applied for bioequivalence studies of digoxin.
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Acknowledgements
The authors are thankful to Ms. Swati Guttikar, Dr. Ajay Gupta, and Dr. Primal Sharma, Veeda Clinical Research, Ahmedabad, for their continuous technical support. The authors are also thankful to Dr. Nitin Bhatnagar Professor, GLA University, Mathura, for editing the manuscript.
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The authors confirm contribution to the paper as follows: study conception and design: GPA, KS; data collection: KS; analysis and interpretation of results: KS; draft manuscript preparation: GPA. All authors reviewed the results and approved the final version of the manuscript.
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Agrawal, G.P., Soni, K. Development of a Bioanalytical Method by UHPLC-ESI-TQD-MS for the Quantification of Digoxin in Plasma. Rev. Bras. Farmacogn. 33, 747–755 (2023). https://doi.org/10.1007/s43450-023-00404-8
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DOI: https://doi.org/10.1007/s43450-023-00404-8