柱前衍生化HPLC法测定异烟肼注射液中游离肼的含量
发布时间：2018-09-18 17:31
【摘要】：目的:建立柱前衍生化高效液相色谱法测定异烟肼注射液中游离肼含量。方法:以苯甲醛为衍生化试剂,将游离肼衍生化为苯甲醛吖嗪,然后进行高效液相色谱测定。采用Ultimate XB-C_(18)色谱柱(250 mm×4.6 mm,5μm),流动相为0.1%乙二胺四乙酸二钠溶液-乙腈(30∶70),流速1.0 m L·min~(-1),检测波长为310 nm,柱温40℃。结果:游离肼质量浓度在2.5~100μg·m L~(-1)范围内与其衍生物的峰面积呈良好线性关系,在低、中、高3个添加水平范围内的平均回收率为96.9%~101.0%,RSD在0.2%~3.0%之间,游离肼的检出限为0.5μg·m L~(-1),定量限为2.5μg·m L~(-1)。3个批次样品的测定结果分别为0.014%、0.043%和0.095%。结论:本文方法为异烟肼注射液的质量控制提供了有效的检测方法。
[Abstract]:Objective: to establish a precolumn derivatization HPLC method for the determination of free hydrazine in isoniazid injection. Methods: benzaldehyde was used as derivatization reagent, free hydrazine was derivatized to benzaldehyde azide, and then determined by high performance liquid chromatography. Ultimate XB-C_ (18) column (250 mm 脳 4.6 mm,5 渭 m),) was used as mobile phase of 0.1% ethylenediamine tetraacetic acid disodium solution-acetonitrile (30:70). The flow rate was 1.0 mL min~ (-1). The detection wavelength was 310 nm, at 40 鈩，
本文编号：2248617
[Abstract]:Objective: to establish a precolumn derivatization HPLC method for the determination of free hydrazine in isoniazid injection. Methods: benzaldehyde was used as derivatization reagent, free hydrazine was derivatized to benzaldehyde azide, and then determined by high performance liquid chromatography. Ultimate XB-C_ (18) column (250 mm 脳 4.6 mm,5 渭 m),) was used as mobile phase of 0.1% ethylenediamine tetraacetic acid disodium solution-acetonitrile (30:70). The flow rate was 1.0 mL min~ (-1). The detection wavelength was 310 nm, at 40 鈩，
本文编号：2248617
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