张磊,刘春亮,王龙娟,等.双波长高效液相色谱法同时测定肠溶片中氨基葡萄糖
和吲哚美辛的含量及含量均匀度[J].安徽医药,2019,23(5):856-859. |
双波长高效液相色谱法同时测定肠溶片中氨基葡萄糖
和吲哚美辛的含量及含量均匀度 |
Determination and uniformity test of glucosamine hydrochloride and indometacin in glucosamine indometacin enteric-coated tablets by HPLC with dual-wavelength |
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DOI:10.3969/j.issn.1009-6469.2019.05.003 |
中文关键词: 色谱法,高压液相 吲哚美辛 回收率 氨糖美辛肠溶片 盐酸氨基葡萄糖 |
英文关键词: Chromatography,high pressure liquid Indomethacin Recovery rate Glucosamine hydrochloride Glucosamine indometacin enteric-coated tablets |
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中文摘要: |
目的 建立氨糖美辛肠溶片中盐酸氨基葡萄糖和吲哚美辛的含量及含量均匀度的测定方法。方法 采用高效液相色谱法,乙腈-磷酸盐缓冲液(取3.5 g磷酸氢二钾和0.25 mL氢氧化铵,加水至1 000 mL,用磷酸调节pH至7.5)(70∶30)为流动相;流速为1.0 mL/min;检测波长为195 nm和254 nm。结果 盐酸氨基葡萄糖在98.10~1 962.00 mg/L范围内呈良好的线性关系,r=0.999 9,平均回收率为99.15%,相对标准偏差(RSD):0.97%(n=9);吲哚美辛在32.86~657.20 mg/L范围内呈良好的线性关系,r=0.999 8,平均回收率为99.28%,RSD:0.66%(n=9)。结论 该方法简便、准确、重复性好,能同时测定氨糖美辛肠溶片中双组分盐酸氨基葡萄糖和吲哚美辛的含量及含量均匀度。 |
英文摘要: |
Objective To establish a method for the determination of glucosamine hydrochloride and indometacin in glucosamine indometacin enteric-coated tablets.Methods The separation was performed on High Performance Liquid Chromatography (HPLC).The mobile phase was acetonitrile and phosphate buffer (dissolve 3.5 g of dibasic potassium phosphate in 1 L water,add 0.25 mL of ammoniumhydroxide,adjust pH to 7.5 with phosphoric acid.) (70∶30).The flow rate was 1.0 mL/min.The detection wavelength was 195 nm and 254 nm.Results The linear range of glucosamine hydrochloride was 98.10-1 962.00 mg/L (r=0.999 9).The average recovery was 99.15% and relative standard deviation(RSD) was 0.97% (n=9).The linear range of indometacin was 32.86-657.20 mg/L(r=0.999 8).The average recovery was 99.28% and RSD was 0.66% (n=9).Conclusion The method is convenient,accurate and reproducible.It can be suitable for the simultaneous determination of glucosamine hydrochloride and indometacin in glucosamine indometacin enteric-coated tablets. |
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