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Different Mathematical Spectrophotometric Methods for Determination of Lesinurad in the Presence of its Oxidative Degradation Product
摘要： Lesinurad is a novel selective uric acid reabsorption inhibitor which has been recently approved for the treatment of the chronic gout. Four simple mathematical spectrophotometric methods have been developed for the quantitative and selective determination of lesinurad in the presence of its oxidative degradation product. Complete oxidative degradation of lesinurad to its degradation product has been done. The developed methods namely, ratio difference spectrophotometric, first derivative of the ratio spectra, mean centering of the ratio spectra and continuous wavelet transform spectrophotometric methods. These methods have been developed and optimized to resolve the existed overlapping between the zero order UV absorption spectra of lesinurad and its oxidative degradation product. The described spectrophotometric methods have achieved selective determination of lesinurad without any interference from the oxidative degradation product. Also, they have been validated and applied for quantitative analysis of the studied drug in its new pharmaceutical preparation.
关键词： Lesinurad,oxidative degradation,spectrophotometric methods
更新于2025-09-23 15:23:52
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Spectrophotometric Methods for Simultaneous Determination of Rivaroxaban and Clopidogrel in Their Binary Mixture
摘要： Three rapid, accurate and very simple derivative spectrophotometric methods for RIV and CLP assay in their binary mixture and tablet dosage forms were developed. Method (I) is first derivative spectrophotometric method, derivative amplitudes were measured at the zero crossing wavelength of 289 and 249.5 nm for estimation of RIV and CLP, respectively. The linearity is over the range 2.0 - 20.0 μg/ml for RIV and 5.0 - 60.0 μg/ml for CLP with LOD of 0.211 and 0.361 μg mL-1 and LOQ of 0.641 and 1.095 μg mL-1 for RIV and CLP, respectively. Method (II) is ratio derivative spectrophotometric method. The ratio spectra of each drug were derived by dividing its spectra on a constant concentration of the other drug as a divisor. Derivative amplitudes were measured at 256 nm for RIV and at 214.5 nm for CLP over the same linearity range as the first method with LOD of 0.137 and 0.485 μg mL-1 and LOQ of 0.417 and 1.471 μg mL-1 for RIV and CLP, respectively. Method (III) is absorbance ratio method, absorbance of both drugs were recorded at two wavelengths λ1 (232) iso-absorptive point and λ2 (249) λmax of RIV. The final concentrations were obtained by applying the Q equations. The method was linear over the same concentration range as the first method with LOD of 0.272 and 0.485 μg mL-1 and LOQ of 0.826 and 1.471 μg mL-1 for RIV and CLP, respectively. The proposed methods were validated as per ICH guidelines. The proposed methods were successfully applied to both drugs analysis in their laboratory prepared co formulated tablet. Statistical comparison of the obtained results with those of the reference method show good agreement and confirm that there were no significant difference in the accuracy and precision between the proposed and reference one respectively.
关键词： Rivaroxaban (RIV),Clopidogrel (CLP),Spectrophotometric methods,Binary mixture
更新于2025-09-23 15:22:29