Five spectrophotometric methods for simultaneous determination of Amlodipine besylate and celecoxib in presence of its toxic impurity

Five simple, selective and accurate spectrophotometric methods have been applied and developed for first time for simultaneous determination of amlodipine besylate (AML) and celecoxib (CEL) in presence of one harmful impurity, 4-methylacetophenone (MAP), in their ternary mixture without prior separation. Those spectrophotometric methods were developed and called: dual wave length in ratio spectra (DWRS), successive ratio-derivative spectra (SDR), modified absorption factor method (MAFM), modified amplitude center method (MACM) and first derivative -zero crossing coupled with amplitude factor method (FDAF). These methods include various steps using zero /or ratio /or derivative spectra and some mathematical techniques. Linear calibration curves were constructed over the concentration range of 2- 100, 10-200 and 0.5-20 mg/mL for AML, CEL and MAP, respectively. High sensitivity with low LOD values 0.583, 3.118 and 0.147 for AML, CEL and MAP, respectively were obtained. Moreover, validation of the proposed methods was achieved according to ICH guidelines and satisfactory results were obtained indicating that the developed methods can be used for quality control analysis of AML and CEL concerning its impurity. No significant difference was observed when the obtained results of the developed methods were statistically compared with the reported HPLC method. (c) 2021 Elsevier B.V. All rights reserved.

Automated summary

Five simple and accurate spectrophotometric methods were developed for the simultaneous determination of AML and CEL in the presence of the harmful impurity MAP in their ternary mixture without prior separation. These methods showed high sensitivity and low LOD values, and were validated according to ICH guidelines. The developed methods were found to be suitable for quality control analysis of AML and CEL with no significant difference compared to the reported HPLC method.