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Stability Indicating RP-HPLC Method for the Determination of Fenoverine in Bulk and Formulation Suganthi A.*, Ravi T.K. College of Pharmacy, SRIPMS, 395, Sarojini Naidu Road, Coimbatore-641044, Tamilnadu, India *Corresponding Author E-mail: suganlemu@gmail.co
Online published on 3 April, 2013. 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. Top Keywords Fenoverine, high performance liquid chromatography, stability, forced degradation. Top | |
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