Asian Journal of Biomedical and Pharmaceutical Sciences

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Stability Indicating High Performance Liquid Chromatographic Method for The Determination of Bromazepam in the presence of its degradation products

A reversed-phase HPLC method was developed and validated for the determination of Bromazepam and its degradation products. The acidic hydrolysis of Bromazepam was carried out in 1N hydrochloric acid solution while the alkaline hydrolysis was carried out in 1N sodium hydroxide solution both at 95°C.Two degradation products were isolated and identi?ed by mass spectroscopy. Spectroscopic data indicated that (2-amino-5-bromophenyl)(pyridine-2-yl) methanone was the degradation product of this acid hydrolysis, whereas 4-bromobenzene- 1,2-diol was the degradation product of the alkaline hydrolysis. A mobile phase consisting Phosphate buffer pH 3.5 Acetonitrile (82:18 v/v) was used, and separation was done on a Zorbax Column C18 dimension 250x 4.6mm, particle size 5µ. Using A flow rate of 1 ml.min-1 while detection wavelength was 240.0nm.Retention times were 3.65, 2.60 and 1.85 for intact Bromazepam, acid and alkaline induced ion products respectively. The method showed good linearity in the concentration range of 20–100 µgmL−1. The intra- and interassay precision RSD% were 0.256 and 0.756 respectively .Statistical comparison between the results obtained for the analysis of Bromazepam in pure form and the reported HPLC method showed that values of the calculated t and F are less than the tabulated ones, which reveals that there is no significant difference between the compared methods with respect to accuracy and precision,

Author(s): Yosra Zakaria Sewilam