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

Abstract

Aim: Green, accurate and rapid methods, namely LC–MS/MS and thin layer chromatography-densitometric methods, were developed for determination of amlodipine besylate and celecoxib in presence of its process-related impurities, 4-methylacetophenone in pure and formulated tablets. Results: LC–MS/MS was achieved on ZORBAX Eclipse Plus C18 column using methanol: aqueous solution of 5 mM formic acid (95:5 v/v). High sensitivity with low limit of detection values 0.00028, 0.00027 and 0.0003 for amlodipine, celecoxib and 4-methylacetophenone, respectively were obtained. While, thin layer chromatography-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.

Novel Validated LC-MS/MS Method For Simultaneous Estimation of Celecoxib and Amlodipine in Rat Plasma and Its Application to A Pharmacokinetic Study

“…Scientists have reported different analytical methods for the quantification of the above fixed dose combination in synthetic mixtures, pharmaceutical formulation and biological fluids. For instance, UV [8][9][10][11][12] , TLC 13 , HPLC [14][15][16] and LC-MS/MS 17 methods have been developed. Overall, 10 studies have been reported for the estimation of Celecoxib and Amlodipine simultaneously among which only two papers had described quantification of the two drugs in biological samples using HPLC and LC-MS/MS.…”