论文部分内容阅读
目的:建立异紫堇碱HPLC含量测定和有关物质检查方法。方法:采用SinoChrom ODS-BP C18柱(4.6 mm×250 mm,5μm),以乙腈-三乙胺调至pH 6.02的0.2%磷酸水溶液(50∶50)为流动相,检测波长为270 nm,流速为1.0 mL·min-1,柱温30℃。结果:异紫堇碱与其相关物质峰完全分离,在30～300μg·mL-1浓度范围内呈良好线性关系(n=6),相关系数r=0.9999,定量限为0.03 ng,最低检测限为0.0075 ng,平均回收率99.4%,RSD=2.9%(n=5)。结论:该方法可准确地进行定性、定量检测且专属性好,精密度、准确度符合要求,方法可靠,可用于异紫堇碱的含量及其相关物质的测定。
OBJECTIVE: To establish HPLC method for the determination of isorhinine and related substances. METHODS: SinoChrom ODS-BP C18 column (4.6 mm × 250 mm, 5 μm) was used as the mobile phase. The mobile phase consisted of acetonitrile-triethylamine 0.2% phosphoric acid solution (50:50) 1.0 mL · min-1, column temperature 30 ℃. Results: Corynebacterium was completely separated from its related substances peak, with a good linearity (n = 6) in the range of 30 ~ 300μg · mL-1, the correlation coefficient was 0.9999, the limit of quantification was 0.03 ng, 0.0075 ng, average recovery 99.4%, RSD = 2.9% (n = 5). Conclusion: This method can accurately and qualitatively and quantitatively detect with good specificity, precision and accuracy to meet the requirements. The method is reliable and can be used for the determination of corydaline and its related substances.