Abstract
Objectives: Glucosamine a natural amino monosaccharide and used for the treatment of osteoarthritis. The main objective of this research is to develop a simple, accurate RP-HPLC method for the determination of impurities in glucosamine 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 of Octane 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 absorbance was measuered at 195 nm. Results/ Conclusion: The developed method was validated as per ICH guidelines with respect to specificity, limit of detection, limit of quantification, precision, linearity, accuracy, robustness and system suitability. Validation
results were found to be satisfactory and the method applicable for bulk and formulation analysis.