Validated Green Chromatographic Methods for Determination of Amlodipine and Celecoxib in Presence of Methylacetophenone

Research Abstract

Background: Green, accurate and rapid methods, namely liquid chromatography-tandem mass spectrometry (LC-MS/MS) and thin layer chromatography (TLC)-densitometric methods, were developed for determination of amlodipine besylate (AML) and celecoxib (CEL)in presence of its process-related impurities, 4-methylacetophenone (MAP) in pure and formulated tablets. Results: LC-MS/MS was achieved on ZORBAX Eclipse Plus C18 columnusing methanol: aqueous solution of 5 mM formic acid (95:5 v/v).High sensitivity with low LOD values0.00028, 0.00027 and 0.0003 for amlodipine, celecoxib and 4-methylacetophenone, respectively were obtained.While,TLC-densitometric was established using methanol: water: ammonia (70: 25: 1.5, by volume). Good linearity was obtained in the range of 0.1-10 µg/band, 1-150 µg/band and 0.01-2 µg/band for amlodipine, celecoxib and 4-methylacetophenone, respectively. Conclusion: The proposed method validation was achieved according to ICH guidelines. Those methods possess advantages of being ecofriendly methods which permit their application in quality control laboratories.

Research Keywords

Amlodipine besylate, Celecoxib, Methylacetophenone, LC-MS/MS, TLC-densitometric method