ABSTRACT
OBJECTIVE: To establish an HPLC method for determination of the related substances and content of glucosamine hydrochloride products from different manufacturers, and evaluate the quality variation of products of three dosage forms from eight different manufacturers. METHODS: The determination method was developed on a Phenomenex Luna NH2 column(4.6 mm × 250 mm, 5 μm), with phosphate buffer (7.0 g dipotassium hydrogen phosphate dissolved in a suitable amount of water, diluted with 0.5 mL ammonia, add water to 2 000 mL, adjusted to pH 7.5 with phosphoric acid)-acetonitrile (25:75) as mobile phase at a flow rate of 1.5 mL· min-1. The column temperature was maintained at 30℃ and detection wavelength was set at 195 nm. RESULTS: The system suitability test met the requirements, and the resolution between the peaks of glucosamine hydrochloride and the impurities were greater than 1.5. Good linearity was shown for glucosamine hydrochloride in the concentration range of 0.156 64-15.664 mg·mL-1 (r=0.999 9). The average recovery rate was 101.14%, with RSD of 1.20% (n=9). CONCLUSION: The established method can be applied in the simultaneous determination of the related substances and content of glucosamine hydrochloride products and provide reference for the quality control.