Abstract

VALIDATED STABILITY – INDICATING HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC AND SPECTROSCOPIC METHODS FOR DETERMINATION OF AGOMELATINE

*Noha S. Rashed, Manal M. Fouad, Ali K. Attia and Reem A. Wasfy

ABSTRACT

Two sensitive, stability- indicating methods for the analysis of agomelatine in the presence of its degradation product have been developed and validated. The first was an HPLC method, in which efficient chromatographic separation was achieved on a C18 column with an isocratic mobile phase of 0.16 % aqueous ortho-phosphoric acid – 0.14 % aqueous triethylamine - methanol (18 : 22 : 60, v/v/v) adjusted to pH 2.5 at flow rate of 1 mL min-1 and UV detection at 230 nm. The second method involved the use of first derivative spectrophotometric measurement of the cited drug at 275 nm. Calibration graphs showed linearity in concentration range of 2-12 and 4-14 ug mL-1 with mean percentage recoveries of 101.7 ± 0.85 and 101.6 ± 0.92 % using the two procedures, respectively. The suggested methods were used to determine the studied drug in bulk powder, laboratory prepared mixtures and pharmaceutical dosage form with good accuracy and precision. The two methods retain their accuracy in the presence of up to 90% or 70% degradant, respectively. Results obtained from the analysis of the drug by the two proposed methods were statistically compared with those of a reported method and showed no significant difference.

Keywords: Agomelatine, HPLC, derivative spectroscopy