Abstract
UV spectrophotometry is an analytical technique used routinely for qualitative and quantitative assay due the low cost and reliability during analysis. An simple, efficient, rapid, sensitive, precise and economical UV Spectrophotometric method has been developed for estimation of agomelatine from bulk and pharmaceutical formulation. The method was developed and validated according to International Conference on Harmonization (ICH Q2 R1) guidelines. The λmax of agomelatine in acetonitrile was found to be 229.6 nm. The analytical method validation parameters linearity, precision, accuracy, robustness were studied according to International Conference on Harmonization guidelines. Pure drug concentration was prepared in the range of 1-10 μg/ml and the linear regression analysis data showed good linear relationship with correlation coefficient value 0.9937. The precision of the method was studied as an intra- day, inter-day variations with value less than 2 % RSD. The limit of detection and limit of quantitation were found to be 0.577 and 1.248 μg/ml, respectively. Recoveries were found to be in the range of 100.815 to 101.744 % and % RSD was less than 2 %. This proposed UV spectroscopic method is simple and suitable for routine analysis.
 Keywords: Keywords: Agomelatine, Validation, UV Spectrophotometric method
Highlights
Agomelatine (AGM) is chemically N- [2-(7methoxy napthalen-1-yl) ethyl] acetamide (Fig.1)
Efficient, rapid, sensitive, precise and economical UV Spectrophotometric method has been developed for estimation of agomelatine from bulk and pharmaceutical formulation
The analytical method validation parameters linearity, precision, accuracy, robustness were studied according to International Conference on Harmonization guidelines
Summary
Agomelatine (AGM) is chemically N- [2-(7methoxy napthalen-1-yl) ethyl] acetamide (Fig.). AGM is an acetamide naphthalene analogue of melatonin. AGM is a novel melatonergic antidepressant agent. It is a potential and well-tolerated medication for the treatment of major depressive disorder. AGM acts as a melatonergic receptor (MT1/MT2) agonist and serotonergic receptor (5-HT2C) antagonist. AGM has proven to have anxiolytic properties and may prove to be very useful in the treatment of anxiety disorders. Because of its action upon the melatonin receptors, AGM shows a marked improvement on sleep. The metabolism of AGM is almost completely hepatic. An extensive first pass hepatic effect is observed. It is practically insoluble in water and very soluble in organic solvents such as ethanol, methanol and dichloromethane
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