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Original Articles

DEVELOPMENT, COMPARISON, AND PEAK VALIDATION OF A HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR DIRECT DETERMINATION OF GLUCOSAMINE HYDROCHLORIDE IN PHARMACEUTICAL FORMULATIONS

, , , , , & show all
Pages 2533-2547 | Published online: 01 Dec 2011
 

Abstract

A simple high-performance liquid chromatography (HPLC) method was developed for the direct determination of glucosamine hydrochloride (GLH) in capsules and tablets. An Alltima C18 column (250 mm × 4.6 mm i.d., 5 µm) was used with 10 mM ammonium dihydrogen phosphate and acetonitrile (95:5, v/v) as the mobile phase at the flow rate of 0.5 mL · min−1. The detection wavelength was 194 nm. The method showed good linearity in the range of 1.0–3.0 g · L−1 with a correlation coefficient of 0.9995. The instrumental and method precisions were satisfactory with all relative standard deviations lower than 2.0%. The accuracy of this method, measured by the recovery of GLH from spiked placebo solutions, was from 98.0% to 102.0%. GLH was well separated from excipients, degradation products, and some common acid radical anions. Method comparison showed this developed method more convenient than a classic spectrophotometric method and more specific than the USP method. Peak validation confirmed that the main chromatographic peak, in the USP method as well as in this developed method, was not the peak response to glucosamine, but actually the peak response to chloridion.

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