目的:建立高效液相色谱-示差折光检测器法测定氨糖美辛肠溶片中盐酸氨基葡萄糖含量。方法:使用 Waters XBridge Amide(4。6 mm ×250 mm，3。5 μm)色谱柱，流动相:80％乙腈溶液(1 000 mL 中含 1 mL氨水)，流速:1。2mL·min-1;柱温:40℃;进样量:20 μL，示差折光检测器(RID)检测。结果:盐酸氨基葡萄糖检测限为0。03 mg·mL-1，定量限为0。125 mg·mL-1，其在0。72～7。56 mg·mL-1质量浓度范围内呈良好的线性关系。平均回收率为99。36％(RSD=0。85％，n=9)。测定氨糖美辛肠溶片7批，盐酸氨基葡萄糖的含量在93％～107％范围内。结论:所建方法检测快速准确、专属性强、耐用性较好，可用于盐酸氨基葡萄糖含量的测定，为有效控制氨糖美辛肠溶片的质量提供参考。
HPLC-RID method for the determination of glucosamine hydrochloride in amitriptyline enteric-coated tablets
Objective:To establish a method for the determination of glucosamine hydrochloride content in amin-oglycine enteric coated tablets by high-performance liquid chromatography with differential refractive detector.Methods:Waters XBridge Amide(4.6 mm ×250 mm,3.5 μm)column was used.The mobile phase was 80％acetonitrile solution(1 000 mL containing 1 mL ammonia)at the flow rate of 1.2 mL·min-1.Column temperature was set on 40 ℃;Injecting volume was 20 μL with differential refraction detector(RID)detection.Results:The detection limit of glucosamine hydrochloride was 0.03 mg·mL-1,and the limit of quantification was 0.125 mg· mL-1.It showed a good linear relationship in the mass concentration range of 0.72-7.56 mg·mL-1.The aver-age recovery was 99.4％(RSD=0.85％,n=9).The content of glucosamine hydrochloride in 7 batches of amin-osamine enteric-coated tablets was measured in the range of 93％-107％.Conclusion:The proposed method is fast,accurate,specific and durable,and can be used for the determination of glucosamine hydrochloride,which provides a reference for effectively controlling the quality of aminoxymetacin enteric-coated tablets.
HPLCRIDenteric-coated tablets of aspartameglucosamine hydrochloridecontent determination
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