Development and Validation of RP-HPLC Method for estimation of Ornidazole in Ornidazole injection 5mg/mL
B.Sucharitha1*, V. Anuradha2
1.Department of Chemistry, Vignan Degree College, Guntur, Andhra Pradesh, India
A new, simple, rapid, selective, precise and accurate isocratic reverse phase high performance liquid Chromatography assay method has been developed for estimation of Ornidazole in injection formulations. The separation was achieved by using column Inertsil ODS-3V (150×4.6 mm, 5µ), in mobile phase consisted of acetonitrile and pH 3.0 phosphate buffer, adjusted to pH 3.0 with the help of dilute orthophosphoric acid in the ratio of (10:90, v/v). The flow rate was 2.0 mL/min-1 and the separated Ornidazole was detected using UV detector at the wavelength of 300 nm. Column temperature 25°C and sample temperature ambient and injection volume 20µL. The retention time of Ornidazole, was noted to be 12.05 min respectively. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and consistent.
Keywords: Liquid Chromatography, Ornidazole, Force degradation and Validation.