Abstract

High performance liquid chromatography, TLC densitometry, firstderivativeand first-derivative ratio spectrophotometry for determination of rivaroxaban and its alkaline degradates in bulk powder and its tablets.

Author(s): Lories I.Bebawy, Azza A.Mostafa2, Marian A.Girge

Four sensitive and selective stability indicating methods for the determination of rivaroxaban (RIV) in the presence of its alkaline degradates (A,B) and in its pharmaceutical formulation were developed. Method A was an isocratic RP-HPLC,good resolution between peaks corresponding to the degradates from analyte was achieved on C18 column using mobile phase of 1.2% w/v potassium dihydrogen phosphate pH 3.5±0.2 and acetonitril (70:30,v/v). The detection was carried out at 280 nm.Method B depends on quantitative densitometric determination of thin layer chromatography (TLC) of rivaroxaban in the presence of its degradates without any interference.chloroform-isobutyl alcohol (50:50 v/v) was used as a developing system. The chromatogramwas scanned at 280 nm.Method C was based on the first derivative (D1) measurement of the drug at 237.4 nm,zero contribution point of its alkaline degradates. Method D was based on the resolution of the drug and its alkaline degradates by first derivative ratio spectra (DD1) and measured the amplitude at 236nm.These methods were successfully applied for the determination of rivaroxaban in bulk powder, pharmaceutical formulation and in presence of its alkaline degradates.The obtained results were statistically analyzed and compared with those obtained by the reported method.