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该文采用系统组织工程技术(ZTSO)快速优化并建立正丁胺含量测定的离子色谱法。选用AcelaimTMTrinityTM P1(3.0 mm×100 mm,3μm)为色谱柱,18 mmol/L乙酸铵(用乙酸调p H 3.4)∶乙腈(56∶44,ν∶ν)为淋洗液,在柱温37℃,流量0.15 m L/min的条件下等度洗脱,电导检测器检测,20 min内完成正丁胺的含量测定。结果表明:正丁胺质量浓度在10.01~500.5μg/m L范围内线性关系良好(r2=0.999 8),检测限为5.05μg/m L(S/N≥3),定量限为10.01μg/m L(S/N≥10),日内和日间精密度分为0.33%和0.90%,正丁胺供试品溶液在24 h内稳定(RSD=0.54%),3批正丁胺原料的平均含量为99.79%(RSD=0.125%),3批肿瘤血管抑制剂XY03中正丁胺的平均含量为20.32%(RSD=4.09%),热干燥时,XY03中铵盐的下降率与其溶解度呈正相关。ZTSO技术具有较好的条件优化功能,所建立的方法快速、简便和准确,是正丁胺或含正丁铵盐化合物含量测定的较好方法。
This paper uses Systemic Tissue Engineering (ZTSO) to rapidly optimize and establish ion chromatography for the determination of n-butylamine. The chromatographic column was AcelaimTM TrinityTM P1 (3.0 mm × 100 mm, 3 μm), and 18 mmol / L ammonium acetate (adjusted to acetic acid p H 3.4): acetonitrile (56:44, ν:ν) ℃, flow rate 0.15 m L / min isocratic elution, conductivity detector detection, n-butylamine content determination within 20 min. The results showed that the linear range of n - butylamine concentration was 10.01 ~ 500.5μg / m L (r2 = 0.999 8), the detection limit was 5.05μg / m L (S / N≥3) and the limit of quantification was 10.01μg / m L (S / N≥10). The intra- and inter-day precision was 0.33% and 0.90% respectively. The n-butylamine solution was stable within 24 h (RSD = 0.54% The average content of n-butylamine in XY03 was 20.32% (RSD = 4.09%). The descending rate of ammonium salt in XY03 was positively correlated with its solubility . ZTSO technology has better conditions to optimize the function of the established method is fast, easy and accurate, n-butylamine or n-butylammonium compounds containing a good method.