HPLC法测定氨糖美辛肠溶片的含量

摘要

目的:建立HPLC法测定氨糖美辛肠溶片中吲哚美辛和盐酸氨基葡萄糖含量.方法:采用Waters BridgeC18(250 mm ×4.6 mm,5 μm)色谱柱,以磷酸二氢铵(以磷酸调节pH至3.0)(A),乙腈(B)为流动相,梯度洗脱,流速为0.7 ml·min-1,检测波长195 nm,进样量为20 μl,柱温30℃.结果:盐酸氨基葡萄糖在0.0300~1.5008 mg·ml-1(r=0.9991),吲哚美辛在0.0103~0.5130 mg·ml-1(r=0.9999)范围内线性关系良好;平均回收率分别为98.3% (RSD =0.33%,n =6);99.9% (RSD=0.06%,n=6).结论:此方法准确、快速、灵敏、专属性强,可较好地控制该产品的质量.%Objective:To establish an HPLC method for the determination of indomethacin and glucosamine hydrochloride in glu-cosomine and indomethacin enteric-coated tablets. Methods:A waters Bridge C18(250 mm×4.6 mm,5 μm) column was used with ammonium dihydrogen phosphate (the pH value was adjusted to 3.0 by phosphoric acid) (A) and acetonitrile (B) as the mobile phase with gradient elution,the flow rate was 0.7 ml·min-1,the detection wavelength was 195 nm,the sample volume was 20 μl and the column temperature was 30℃. Results: Glucosamine hydrochloride and indomethacin had a good linear relationship within the range of 0.030 0-1.500 8 mg·ml-1(r=0.999 1) and 0.010 3-0.513 0 mg·ml-1(r=0.999 9), and the average recovery was 98.3%(RSD=0.33%,n=6)and 99.9%(RSD=0.06%,n=6), respectively. Conclusion: The method is accurate, rapid, sensi-tive and specific,and can be used to control the quality of the product.