A RAPID CHROMATOGRAPHIC/MASS SPECTROMETRIC METHOD FOR DIGOXIN QUANTIFICATION IN HUMAN PLASMA

作者：Grabowski T^*; Swierczewska A; Borucka B; Sawicka R; Sasinowska Motyl M; Gumulka S W; Zahariev Y; Mitova A; Zhilkova K

来源：Pharmaceutical Chemistry Journal, 2009, 43(12): 710-715.

DOI：10.1007/s11094-010-0384-y

• digoxin
• UPLC
• bioequivalence
• pharmacokinetics

The relatively simple liquid-liquid extraction LC-MS/MS method using a UPLC column for measurement of digoxin concentrations both in medium and human plasma is described. Digitoxin was used as internal standard. The developed method possesses satisfactory accuracy, precision, and repeatability, and is economical and not time-consuming. It is the first method for precise measurement of digoxin concentrations in human plasma using combined HPLC equipment and UPLC column with a low limit of quantitation equal to 0.1 ng ml (1) as verified in more than 1500 samples analyzed in a GCP GLP bioequivalence study. The developed method was successfully used in digoxin bioequivalence studies in which 26 volunteers were enrolled.

• 出版日期2009-12