Novel UV Spectrophotometer Methods for Quantitative Estimation of Concensi (Amlodipine 10mg and Celecoxib 200mg) Using Hydrotropic Solubilizing Agents

摘要

Two simple, accurate, novel, safe and precise methods were developed for the simultaneous estimation of poorly water-soluble drugs Amlodipine besylate (AMD) and Celecoxib (CLX) in a in-house formulation using 2M sodium benzoate as a hydrotropic solution. AMD and CLX show maximum absorbances at 243 and 255 nm, respectively. Sodium benzoate did not show any absorbance above 225 nm and thus no interference in the estimation of drugs was seen. AMD and CLX follow Beer’s law in the concentration range of 2-10mg/ml and 10-50mg/ml (rsup2/sup = 0.9992 and 0.9995). Method-A employs the simultaneous equation method using 243 and 255 nm as two analytical wavelengths; method-B employs the absorption ratio method, which uses 243 and 250nm as two analytical wavelengths for estimation of AMD and CLX. The mean percent label claims of in-house formulation were found to be 98.74± 0.912and 99.22± 1.012in method-1, 97.89± 0.872and 99.49± 0.903 in method 2 for AMD and CLX, respectively. The developed methods were validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values therefore both methods can be used for routine monitoring of AMD and CLX in industry in the assay of bulk drug and pharmaceutical formulation.