高效液相色谱法测定吲哚美辛栓的含量及有关物质

 目的采用HPLC测定吲哚美辛栓的含量及有关物质。方法采用Waters-C₁₈(4.6mm×25cm,5μm)色谱柱,以乙腈-0.1mol·L^-1冰醋酸溶液(50:50)为流动相;检测波长为228nm。结果在选定的色谱条件下,有关物质与主药分离良好,两种杂质的最小检出量均为0.1ng。在5.2～516mg·L^-1内,有良好的线性关系,r=0.9996;平均回收率为100.1%(RSD为0.6%,n=9)。结论该方法测定灵敏、选择性、重现性好,可以用于本品的含量测定和有关物质的检查。

Determination of indometacin suppository and relative substances by HPLC

OBJECTIVE To establish a HPLC method for the determination of indometacin suppository and its relative substances. METHODS The separation was performed on a Waters-C₁₈(4.6 mm×25 cm,5 μm)with acetonitrile-0.1 mol·L^-1 glacial acetic acid solution(50:50) as mobile phase at a flow rate of 1 mL·min^-1. The detection wavelength was 228 nm.RESULTS The relative substances were completely separated from indometacin. For indometacin, a linear range of 5.2～516 mg·L^-1 (r=0.999 6) was obtained, the average recovery was 100.1% (RSD=0.6%,n=9) .CONCLUSION This method is selective, accurate and reproducible. It can be used in the determination for indometacin and its relative substances in indometacin suppository.