摘要
建立了以甲醇醋酸钠溶液（体积比为１２∶８８）为流动相，同时分离和测定制药生产流程中的异烟肼、异烟酰胺、异烟酸和４氰基吡啶的高效液相色谱法。方法各组分的质量浓度线性范围和检出限分别为：异烟肼０１１～１０６０ｍｇ／Ｌ和０１１ｍｇ／Ｌ；异烟酰胺和异烟酸００７～１０２０ｍｇ／Ｌ和００７ｍｇ／Ｌ；４氰基吡啶０２６～１０２３ｍｇ／Ｌ和０２６ｍｇ／Ｌ。对高含量组分测定７次，其ＲＳＤ＜１％，微量组分的ＲＳＤ＜１０％。
A HPLC method for the simultaneous determination of isoniazid, isonicotic acid, isonicotinamide and 4 CN pyridine in drugs is developed by using CH 3OH 1 g/L NaAc( V CH 3OH ∶ V NaAc =12∶88) solution as eluent. The calibration curves are linear with the concentration in ranges of 0.07～1020 mg/L for isonicotic acid and isonicotinamide, 0.11～1060 mg/L for isoniazid and 0.26～1023 mg/L for 4 CN pyridine. The detect limits are 0.07 mg/L for isonicotic acid and isonicotinamide, 0.11 mg/L for isoniazid and 0.26 mg/L for 4 CN pyridine. The method is rapid, sensitive and reliable.
关键词
高效液相色谱
同时测定
异烟肼
异烟酸
high performance liquid chromatography(HPLC)
simultaneous determination
isoniazid
isonicotic acid
isonicotinamide
4 CN pyridine
