ABSTRACT:
A simple, sensitive and precise RP-HPLC method was developed and validated for the determination of fenoverine (antispasmodic) in presence of its degradation products. Fenoverine and all the degradation products were resolved on a C18 column with the mobile phase composed of methanol, acetonitrile and 10mM ammonium formate (70:10:20, v/v/v) at 258 nm using a photodiode array detector. The method was linear over the concentration range of 5–50 µg mL–1 and precise with RSD < 2 % in intra- and inter-day study. Excellent recoveries of 100.57±1.692 to 101.40±0.6145 proved the accuracy of the method. Developed method was specific, as indicated by chromatographic resolution > 2.0 for each peak and sensitive with LOD 50 ng mL-1 and LOQ 0.5 µg mL–1. The method was used to study the drug degradation behavior under forced conditions. Two degradation products were formed during the degradation study in 6% H2O2 and water whereas only one degradation product in 1 mol L–1 HCl, 0.01 mol L–1 NaOH and photolytic degradation. The method was applied successfully for the assay of fenoverine in the capsule dosage form.