【摘要】 目的:建立测定盐酸非那嗪奈原料药的含量及其有关物质的HPLC法,为盐酸非那嗪奈原料药制定质量控制标准。方法:采用Waters Spherisorb苯基柱(250mm×4.6mm,5μm),0.01mol/L磷酸氢二铵和0.01mol/L五水合氢氧化四甲基铵缓冲液(磷酸调pH至3.0)-甲醇-乙腈(1∶2∶4)为流动相;检测波长为254nm;柱温30℃;流速1.0mL/min。结果:主峰能与相邻杂质峰较好分离,盐酸非那嗪奈的浓度在1.0~200μg/mL范围内线性关系良好,r为0.9999。结论:该法简便、准确、专属性好,可用于盐酸非那嗪奈原料药的含量及有关物质的测定。更多还原

【Abstract】 Aim:To develop an HPLC method for the determination of fenazinel dihydrochloride and its related substances. Methods:The chromatographic separation was performed on a Waters Spherisorb column (250 mm×4.6mm,5 μm) held in the oven of 30 ℃. The mobile phase consisted of phosphate buffer (0.01 mol/L diammonium hydrogen phosphate and 0.01 mol/L pentahydrate tetramethyl ammmonium hydroxide, adjusted to pH 3.0 with phosphoric acid), methanol and acetonitrile(1∶2∶4). The flow rate was 1.0 mL/min and UV detection wavelength was 254 nm. Results:There was fair resolution between fenazinel dihydrochloride and its related substances. The calibration of the responses of fenazinel dihydrochloride ranged from 1.0 to 200 mg/mL with the correlation coefficient of 0.999 9. Conclusion:The method proves to be quick, simple and sensitive. It could be applied for the determination of fenazinel dihydrochloride and its related substances.更多还原