3RD INTERNATIONAL CONGRESS ON TECHNOLOGY - ENGINEERING & SCIENCE - Kuala Lumpur - Malaysia (2017-02-09)

Hplc And Tlc Methods For Simultaneous Determination Of Citalopram Hydrobromide And Clonazepam Using The Quality By Design Approach

Citalopram (CT)is used to treat depression associated with mood disorders. CT belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRIs) which prevent the uptake of serotonin by nerve cells after it has been released . Clonazepam (CLO) is a benzo diazepine derivative and a highly potent anticonvulsant, amnestic and anxiolytic. CLO has shown itself to be useful as a short-term adjunct to SSRI treatments in clinical depression and obsessive compulsive disorder, and this combination is superior to SSRI treatments alone. The aim of this work was to develop accurate, sensitive and validated methods for simultaneous determination of CT and CLO drugs in presence of degradation products without prior separation and in pharmaceutical preparation without interference from excipients. Two stability indicating chromatographic methods have been developed for simultaneous determination of Citalopram Hydrobromide and Clonazepam in presence of alkaline and oxidative degradation products of citalopram Hydrobromide in laboratory prepared mixtures. The first method was based on RP-HPLC using Agilent C18 column (150mm×4.6 mm, 5 μm particle size i.d.) and utilizing a mixture of acetonitrile and phosphate buffer (pH 4.5) in a ratio of (37:63, v/v) as a mobile phase. Quantification was achieved with UV detection at 230 nm. The Quality by Design approach was used for method optimization of the flow rate, column temperature and the pH of the mobile phase and to achieve a satisfactory robustness study. The second method depended on densitometric thin layer chromatography where the separation was achieved using silica gel 60F(254) plates and ethyl acetate: methanol: formic acid: acetic acid: toluene in a ratio of (8: 3: 0.5: 0.5: 5, by volume) as a mobile phase. The validation parameters of the developed methods were calculated and the results obtained were statistically compared with those of the HPLC manufacturer method
Marianne Nebsen, Christine El-Maraghy, Sawsan Amer, Hesham Salem