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摘要
Four sensitive and precise stability-indicating methods for the determination of rebamipide (REB) in the presence of its acid-degradation products and in a pharmaceutical formulation were developed and validated. Method A used the first derivative of the ratio spectra ((DD)-D-1) spectrophotometric method by measuring the peak amplitude at 249.4 nrn (maximum) and at 259 nm (minimum), and at the total peak amplitude (from 249.4 to 259 nm, (DD)-D-1 (249.4 + 259 nm)) in the range of 2-14 mu g/mL. This method yielded mean recoveries of 99.87 +/- 0.83, 100.04 +/- 0.75, and 100.28 +/- 1.11%, respectively. Method B is a dual wavelength method, which allows the determination of REB in presence of its acid-degradation products by measuring the absorbance difference between 254 and 269 nm within a linearity range of 5-65 mu g/mL; it showed a mean recovery of 99.84 +/- 1.06. Method C is a TLC-densitometric procedure in which REB was separated from its degradation products using a developing solution of methanol chloroform ammonia (8.5 + 1.5 + 0.5, v/v/v). The quantitative evaluation of REB at 329 nm was linear over the concentration range of 0.50-4.5 mu g/band, with a mean recovery of 99.49 +/- 0.99% even in the presence of up to 90% degradation products. Method D is an RP-HPLC procedure. It provided the complete separation of REB from its degradation products on an Xterra (TM) C-18 column using phosphate buffer (pH 6, 0.01 M)-methanol (1 + 1, v/v) as the mobile phase (UV detection at 254 nm). Recovery was 99.28 +/- 0.78% within the range of 10-190 mu g/mL. The selectivity of the proposed methods was checked using laboratory-prepared mixtures. The proposed methods have been successfully applied to the analysis of REB in pharmaceutical dosage forms without interference from other dosage form excipients.
- 出版日期2014-2
