Development and Validation of Stability Indicating RP-HPLC Method for Quantitative Estimation of Ornidazole and its Impurities in Ornidazole Injection

Abstract

The analysis of improved RP-HPLC method for the separation and quantification of Ornidazole and its impurities are described. Samples are analysed by means of reverse phase (RP-HPLC) using an Symmetry shield RP18, 250 x 4.6 mm, 5µm, and the mobile phase consists of phosphate buffer: methanol in the ratio of 70:30 %v/v. The flow rate is 1.0 ml/min. The column temperature was maintained at 25°C and sample temperature was maintained at ambient (25°C) and wavelength fixed at 318nm UV-detection. It is found that the method of RP-HPLC with UV-detection system for the analysis of Ornidazole impurities are straight forward and applied in qualitative and quantitative analysis. The developed LC method was validated with respect to specificity, precision, linearity, accuracy, solution stability and robustness. Validation study compared as per ICH guideline.