Elham A Taha
Egypt
Research Article
Stability-Indicating Chromatographic Methods for Determination of Agomelatine in Drug Substance and Drug Product
Author(s): Mohamed Rizk, Elham A Taha, Maha M Abou El-Alamin and Yasmine M SayedMohamed Rizk, Elham A Taha, Maha M Abou El-Alamin and Yasmine M Sayed
Three sensitive and validated chromatographic methods were developed for determination of Agomelatine (AGO) in the presence of its degradation products in drug substance and drug product. The first and second methods were normal thin layer chromatographic (NP-TLC) and reversed phase thin layer chromatographic (RP-TLC) methods. Mobile phase consisting of ethyl acetate-ammonia (33%)-methanol (8.5:0.5:1, v/v/v) was used for NP-TLC while for RP-TLC using 0.1% triethylamine (TEA): acetonitrile (60:40 v/v) at pH=2. The chromatograms were scanned at 230 and 280 nm and determined in the range of 0.1-4 and 0.3-4 μg/spot with mean percentage recovery of 99.89 ± 1.141 and 100.01 ± 1.062 for NP-TLC and RP-TLC respectively. The third method was Micellar Liquid Chromatographic (MLC) method using C18 column and a mobile phase consisting of 0.1 M Sodium Dodecyl Sulphate (SDS), 15% bu.. View More»
DOI:
10.4172/2153-2435.1000531