Determination of Related Substances and Content of Glucosamine Hydrochloride by HPLC
SHEN Dan-dan1,2, ZENG Jie1,2, WANG Yue 3, ZHANG Tao4*
1. Chongqing Institute for Food and Drug Control, Chongqing 401121, China; 2. Chongqing Research Center for Drug Process and Quality Control Engineering, Chongqing 401121,China; 3. Central South University, Changsha 410013, China; 4. Fuan Pharmaceutical Lybon Pharm-tech Co.,Ltd, Chongqing 401121, China
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 ��m) , 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.
��, ����, ���h, ����. HPLC�ⶨ���ᰱ���������й������뺬��[J]. �й�ҩѧ��־, 2017, 52(4): 314-318.
SHEN Dan-dan, ZENG Jie, WANG Yue , ZHANG Tao. Determination of Related Substances and Content of Glucosamine Hydrochloride by HPLC. Chinese Pharmaceutical Journal, 2017, 52(4): 314-318.
ZHENG K X,LIAO H J. Observation of 39 cases of knee osteoarthritis treated with glucosamine as adjuvant therapy [J]. China Contemp Med(����ҽѧ),2015,21(27):134-135.
[2]
NAKAMURA H. Application of glucosamine on human diseas-Osteoarthritis[J]. Carbohydr Polym,2011,84(2):835-839.
[3]
EP 8.0(ŷ��ҩ��8.0��)[S]. 2013:2338.
[4]
USP 35(����ҩ��35��)[S]. 2012:1334.
[5]
YANG H,WANG Z Y. Determination of glucosamine hydrochloride in glucosamine hydrochloride capsules by HPLC-ELSD [J]. J Huaiyin Teachers College(����ʦ��Ժѧ��),2015,14(1):48-51.
[6]
LIU S T,LI S,YIN H P,et al. Determination of acetylglucosamine in glucosamine by HPLC [J]. Chin J Pharm Anal(ҩ�������־),2015,35(5):900-905.
[7]
HUA Y,YANG Z F. Determination of N-acetylglucosamine in glucosamine sulfate by HPLC [J]. Northern Pharm(����ҩѧ),2014,11(5):19.
[8]
CHEN B W,XU Q J,ZHAO X, et al. Determination of 5-hydroxymethylfurfural in glucosamine hydrochlorideby high-performance liquid chromatography [J]. Pharm Biotechnol(ҩ�����＼��),2014, 21(5):441-444.
2017, Vol. 52 
