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.
Keywords:
- amlodipine besylate
- celecoxib
- methylacetophenone
- LC–MS/MS
- TLC-densitometric method