engleski

Development of method for determination of impurities in nepafenac by supercritical fluid chromatography

Nepafenac is chemically described as 2-amino-3- benzoylbenzeneacetamide manufactured as a 0.1% suspension for topical ophthalmic use and it belongs to a group of nonsteroidal anti- inflammatory drugs (NSAID). A novel simple, fast and efficient supercritical fluid chromatography (SFC) method was developed and compared with reversed-phase liquid chromatography (RPLC) method for the separation and determination of impurities in Nepafenac. Overall satisfactory resolutions and peak shapes for Nepafenac, 2- aminobenzophenone, Cl- thionepafenac, Thionepafenac, Cl-Nepafenac, Hydroxy Nepafenac and Cyclic Nepafenac were obtained by optimization of the chromatography system. With the gradient elution of mobile phase, all of the impurities and the active ingredient were separated within 6 min. Taking full advantage of features of SFC (such as particular selectivity, non-sloping baseline in gradient elution, and without solvent injection effects), the method was successfully used for determination of impurities in Nepafenac. More impurity peaks were detected, better resolution was achieved and much less analysis time was needed in comparison with conventional RPLC methods. The developed SFC method is validated with respect to specificity, LOD, LOQ, linearity, precision, accuracy and robustness.

supercritical fluid chromatography ; nepafenac

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