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目的:建立高效液相色谱法,测定乙胺吡嗪利福异烟片中利福平、异烟肼、吡嗪酰胺和盐酸乙胺丁醇含量。方法:利福平、异烟肼和吡嗪酰胺用C_(18)色谱柱(150mm×4.6mm,5μm),以-0.01M磷酸二氢钾溶液-乙腈为流动相进行梯度洗脱,流速1.0ml·min~(-1),检测波长254nm。盐酸乙胺丁醇选用C_(18)色谱柱(150mm×4.6mm,5μm),四氢呋喃-0.4%庚烷磺酸钠(含有0.016%硫酸铜,用磷酸调pH至4.5)(25:75)为流动相,流速1.0ml·min~(-1),检测波长258nm。结果:利福平、异烟肼、吡嗪酰胺及盐酸乙胺丁醇线性范围分别为16～160μg·ml~(-1)(r=0.9999),16～160μg·ml~(-1)(r=0.9999),53～532μg·ml~(-1)(r= 0.9998),80～320μg·ml~(-1)(r=0.9998),平均回收率为99.3%～99.5%。结论:方法简便,准确,可用于乙胺吡嗪利福异烟片中各组分的质量控制。
OBJECTIVE: To establish a method for the determination of rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride in ethylamine pyrazole and rifampin tablets by HPLC. Methods: Rifampicin, isoniazid and pyrazinamide were eluted with C18 column (150 mm × 4.6 mm, 5 μm) and eluted with -0.01 M potassium dihydrogen phosphate solution - acetonitrile as mobile phase at a flow rate of 1.0 ml · min ~ (-1), detection wavelength 254nm. Ethambutol hydrochloride was selected on a C 18 column (150 mm × 4.6 mm, 5 μm), tetrahydrofuran-0.4% sodium heptanesulfonate (containing 0.016% copper sulfate, adjusted to pH 4.5 with phosphoric acid) (25:75) Mobile phase, flow rate 1.0ml · min ~ (-1), detection wavelength 258nm. Results: The linear ranges of rifampin, isoniazid, pyrazinamide and ethambutol hydrochloride were 16 ~ 160μg · ml -1 (r = 0.9999), 16 ~ 160μg · ml -1 ( r = 0.9999), 53 ~ 532μg · ml ~ (-1) (r = 0.9998) and 80 ~ 320μg · ml ~ (-1) (r = 0.9998) .The average recoveries ranged from 99.3% to 99.5%. Conclusion: The method is simple and accurate and can be used for the quality control of each component of ethylamine pyrazine Fufang Yizhen Tablets.