Stability-Indicating HPLC Methods for Determination of Duloxetine HCl in Bulk Drug and Pharmaceutical Formulations with Structure Elucidation of Degradation Products and Determination of Degradation Reaction Kinetics

Maha F. Abdel-Ghany a1, Nermine V. Faresa2, and Eman W. E. Faragb*

aAin Shams University, Faculty of Pharmacy, Analytical Chemistry Department, Abbassia, Cairo 11566, EGYPT bAmoun Pharmaceutical company, Obour City, Industrial Zone (1), Block 13015, Qhalubeya, EGYPT

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The present study describes the development and subsequent validation of a stability-indicating method for determination of [Duloxetine HCl] in the presence of its degradation products, using isocratic RP-HPLC chromatographic techniques. In the HPLC technique; Agilent eclipse XDB-C18 250 x 4.6 mm, 5 µm column was used as a stationary phase, “40% ACN, 60% (0.1% phosphoric acid + 0.2% triethylamine) pH 2.4 ± 0.05 ” as a mobile phase, wavelength measurement at 230nm. The utilized chromatographic methods were validated according to the International Conference on Harmonization (ICH) guidelines and successfully applied for determination of the studied drug in pure form, in laboratory prepared mixtures and in pharmaceutical formulations with good extraction recoveries. HPLC/MS method was used for structure elucidation of degradation products. Kinetics of degradation reaction was studied. All the results were statistically compared with reference method, where there is no significant differences found. The developed methods were satisfactorily applied to analysis of the investigated drugs and proved to be specific and accurate for quality control of them in pharmaceutical formulations.

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