摘要
目的:建立HPLC法测定异烟肼含量及有关物质。方法:采用C18柱(250mm×4.6mm,5μm);流动相:甲醇-0.010mol·L-1辛烷磺酸钠溶液-三乙胺(30∶70∶0.1),用2mol·L-1磷酸调pH至3.00±0.05;柱温:30℃;流速:1.0mL·min-1;检测波长:254nm。结果:异烟肼与异烟酸及其他降解产物分离良好,在含量测定项下,异烟肼在0.05～0.50mg·L-1范围内线性关系良好(r=0.9999);异烟肼和异烟酸的最低检测限分别为0.10,0.098ng。结论:本法专属性强,结果准确、灵敏,操作简便,可作为本品的质量控制方法。
Objective：To establish an HPLC method for the determination of content and related substances of isoniazid. Methods：A C18 column（250 mm · 4. 6 mm,5 μm） was used. The mobile phase was prepared as follows： methanol -0. 010 mol · L^-1 sodium - 1 - octanesulfonate - triethylamine （30： 70： 0. 1 ,adjust pH 3.00±0. 05 with 2 mol · L^-1 phosphoric acid）. The flow rate was 1.0 mL · min^-1. The detection wavelength was 254 nm. Results： Isoniazid was successfully separated from isonicotinic acid and other degradation products. The calibration curve for isoniazid was liner in the range of 0. 05 - 0. 50 mg · L^-1 （ r = 0. 9999）. The detection limit for isoniazid, isonicotinic acid were 0. 10,0. 098 ng, respectively. Conclusion： The method is specific, accurate, sensitive and simple, and can be used for quality control of isoniazid.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2009年第6期1027-1030,共4页
Chinese Journal of Pharmaceutical Analysis
关键词
异烟肼
异烟酸类
含量
有关物质
HPLC
isoniazid
isonicotinic acid
content
related substances
HPLC
