Tag: RP-HPLC method development

Abstract Objectives: Glucosamine a natural amino monosaccharide and used for the treatment of osteoarthritis. The mainobjective of this research is to develop a simple, accurate RP-HPLC method for the determination of impurities inglucosamine hydrochloride drug substance and drug product.Methods: Chromatographic separation was achieved by using Kromasil 100-5C18 300 X 4.0 mm, 5 μm column,mobile phase composed of phosphate buffer (0.8 gm of phosphoric acid, 1.0 ml of Triethylamine and 1.2 gm ofOctane sulphonic acid Sodium salt in 1000 ml of HPLC grade water) and acetonitrile in the ratio of 90:10 (v/v).Column temperature maintained at 25°C, 10μL injection volume and run time was 30min. Analytes absorbancewas measuered at 195 nm.Results/ Conclusion: The developed method was validated as per ICH guidelines with respect to specificity, limitof detection, limit of quantification, precision, linearity, accuracy, robustness and system suitability. Validationresults were found to be satisfactory and the method applicable for bulk and formulation analysis. [avf_view name="Article Addons" view-id="66d98451c48e3"]