HPLC and spectrophotometric determination of nifuroxazide and its pharmaceutical formulations

ABSTRACT

Two methods for the quantitative determination of nifuroxazide are described. The first method is based on the HPLC separation of the compound with an ODS reversed phase column using acetonitrile-water [4060] as mobile phase and spectrophotometric detection at 380 nm. Accelerated stability tests in direct sun light and at elevated temperature were carried out. The second one is a spectrophotometric procedure based on the interaction of the drug with tetraethylammonium hydroxide [TEAH] in dimethylsulphoxide [DMSO] medium at 20 +/- 5C to produce a blue product. The quantitation of the product was carried out at 610 nm [molar absorptivity 2.99 x 104 1 mol-1 cm-1]. A linear correlation was found between absorbance at lambda max and concentration of nifuroxazide in the range 0.5-9.0 mugml1. The two proposed methods were used for the determination of nifuroxazide powder and its dosage form. Both methods are rapid, accurate, precise and their results were comparable with the X-th French pharmacopoeial procedure