高效液相色谱法测定氨糖美辛肠溶片中吲哚美辛含量

摘要

Objective To establish a HPLC method for determining the indomethacin content in Glucosomine and Indomethacin Enteric Coated Tablets. Methods The chromatographic column,was the Thermo-C18 column(250 mm × 4. 6 mm,5 μm),with the mobile phase of acetonitrile -0. 1% glacial acetic acid solution(50 :50),the flow rate was 1. 0 mL/min,the column temperature was 30 ℃ and the detection wavelength was 228 nm. Results The sample size of indomethacin in the range of 0. 511 5-3. 069 0 μg ( r=0. 999 8 ) showed good linear relationship with the peak area,the average recovery rate was 99. 57%,RSD=0. 42%( n=9). Conclusion This method is accurate,sensitive,reproducible,which can be used for the determination of the indomethacin content in Glucosomine and In-domethacin Enteric Coated Tablets.%目的：建立测定氨糖美辛肠溶片中吲哚美辛含量的高效液相色谱法。方法色谱柱为Thermo－C18柱（250 mm ×4.6 mm，5μm），流动相为乙腈－0.1%冰醋酸溶液（50：50），流速为1.0 mL/min，柱温为30℃，检测波长为228 nm。结果吲哚美辛进样量在0.5115~3.0690μg范围内与峰面积呈良好线性关系，r=0.9998，平均回收率为99.57%，RSD=0.42%（ n=9）。结论该方法准确、灵敏、重复性好，可作为氨糖美辛肠溶片中吲哚美辛的含量测定。