Determination of ornidazole in pharmaceutical preparations by ultra performance liquid chromatography

Since the past years with the particle technology developed, Ultra performance liquid chromatography (UPLC) has proven to be an advanced technique from traditional high-performance chromatography (HPLC) with better separation, more selective and faster analysis time. Ornidazole is a slightly soluble in water, 5-nitroimidazole-derived molecule used for treat amebic infection. Within the scope of this thesis to develop and validate a new method, using UPLC to perform a quantitative analysis of Ornidazole and Impurity A in pharmaceutical preparations. In the developed method; a UPLC BEH C18 (50 x 2.1 mm, 1.7 µm) was used as a column. Chromatographic separations were performed at a flow rate of 0.4 mL/min by gradient elution of acetonitrile and acetate buffer. The wavelength of 312 nm was chosen for the detection. According to The International Conference on Harmonization (ICH) guidelines, the pharmaceutical preparation was exposed to various forced degradation conditions, including oxidation, thermal degradation and under acidic and basic conditions. Linearity was carried out to found from between 0.02 to 0.80 μg/mL for Ornidazole and between 0.04 to 1.58 μg/mL for Impurity A. The ranges of the detection and quantitation limits for Ornidazole were found to 0.014 and 0.042 μg/mL respectively and the ranges of the detection and quantitation limits for Impurity A were found to 0.010 and 0.029 μg/mL respectively. The correlation coefficients calculated for Ornidazole and Impurity A were found to be higher than 0.99. Average recovery values for Ornidazole and Impurity A were determined in the range of 95.00%-105.00%. The results obtained for this newly developed analytical method were evaluated statistically. It has been determined that the developed method is simple, selective and reproducible and can be used safely in the analysis of pharmaceutical preparations of Ornidazole.