Simultaneous HPLC determination of chlordiazepoxide and mebeverine HCl in the presence of their degradation products and impurities

A simple,rapid,and sensitive rp-hplc method was developed and validated for the simultaneous determination of chlordiazepoxide (cdo) and mebeverine hcl (mbv) in the presence of cdo impurity (2-amino-5-chlorobenzophenone,acb) and mbv degradation product (veratric acid,ver). separation was achieved within 9 min on a bds hypersil phenyl column (4.5 mm × 250 mm,5 μm particle size) using a mobile phase consisting of acetonitrile: 0.1 m potassium dihydrogen phosphate: triethylamine (35: 65: 0.2,v/v/v) in an isocratic mode at a flow rate of 1 ml/min. the ph of the mobile phase was adjusted to 4.5 with orthophosphoric acid and uv detection was set at 260 nm. a complete validation procedure was conducted. the proposed method exhibited excellent linearity over the concentration ranges of 1.0-100.0,10.0-200.0,2.0-40.0,and 2.0-40.0 μg/ml for cdo,mbv,ver,and acb,respectively. the proposed method was applied for the simultaneous determination of cdo and mbv in their coformulated tablets with mean percentage recoveries of 99.75 ± 0.62 and 98.61 ± 0.38,respectively. the results of the proposed method were favorably compared with those of a comparison hplc method using student t-test and the variance ratio f-test. the chemical structure of mbv degradation product was ascertained by mass spectrometry and ir studies. © 2015 rania n. el-shaheny and fathalla f. belal.