DEVELOPMENT AND VALIDATION OF CHROMATOGRAPHIC TECHNIQUE FOR ANALYSIS OF PROPAFENONE

Abstract

Objective: A simple, sensitive and rapid performance liquid chromatography/positive ion electrospray tandem mass spectrometry method was to be developed and validated for quantification of propafenone (PPF) and its major metabolite 5-hydroxy propafenone (5-OHP) in human plasma.

Methods: L Analytes were separated on an Thermo Betabasic C8, 100 mm X 4.6 mm, 5µ, column maintained at temperature of 40^oC. An isocratic flow-rate of 1.0 mL/minute with  1:1 splitted post column with mobile phase Methanol and MilliQ water (80:20 v/v) with 0.1% formic  acid  of  total  volume  was  used  for  chromatographic  separation.. The multiple reaction monitoring  transitions were set at 342.2 > 116.2 (m/z), 358.2 > 116.2 (m/z), and 349.2 > 123.2  (m/z)  Propafenone, 5-Hydroxypropafenone and Propafenone D7 respectively.

Results:  The analytical method described above is valid for the analysis of Propafenone , and 5- Hydroxypropafenone in human plasma over a range of 0.499 ng/mL to 1502.841 ng/mL  and 0.496 ng/mL to 504.079 ng/mL, respectively, in human plasma.

Conclusion: The validated method has been successfully used to analyze human plasma samples for application in pharmacokinetics, bioavailability and bioequivalence studies.