Stability-indicating chromatographic methods for determination of flecainide acetate in the presence of its degradation products; isolation and identification of two of its impurities
ABSTRACT: In this work, two stability-indicating chromatographic methods have been developed and validated for determination
of flecainide acetate (an antiarrhythmic drug) in the presence of its degradation products (flecainide impurities; B and D).
Flecainide acetate was subjected to a stress stability study including acid, alkali, oxidative, photolytic and thermal degradation.
The suggested chromatographic methods included the use of thin layer chromatography (TLC-densitometry) and highperformance
liquid chromatography (HPLC). The TLC method employed aluminum TLC plates precoated with silica gel G.F
as the stationary phase and methanol–ethyl acetate–33%ammonia (3:7:0.3, by volume) as the mobile phase. The chromatograms
were scanned at 290 nm and visualized in daylight by the aid of iodine vapor. The developed HPLC method used a RP-C
column
with isocratic elution. Separation was achieved using a mobile phase composed of phosphate buffer pH3.3–acetonitrile–
triethylamine (53:47:0.03, by volume) at a flow rate of 1.0 mL/min and UV detection at 292 nm. Factors affecting the efficiency
of HPLC method have been studied carefully to reach the optimum conditions for separation. The developed methods were
validated according to the International Conference on Harmonization guidelines and were applied for bulk powder and dosage
form