摘要
建立了HPLC法同时测定R-四氢罂粟碱中的8个有关物质。根据化合物结构,选择C18填料色谱柱,并依据药典记载对色谱柱及色谱条件进行筛选。结果表明:采用Kromasil 100-5 C18(4.6 mm×250 mm,5μm)色谱柱,以10.0 g/L的甲酸铵-乙腈(100∶5)为流动相A,甲醇为流动相B,梯度洗脱;柱温37℃,检测波长280nm,流速为1.0mL/min,进样量10μL,可同时测定R-四氢罂粟碱中的8个有关物质,分离度均大于1.5;各化合物在0.5~10.0μg/mL范围内,相关系数R2≥0.9999,线性良好,重现性强,灵敏度高,可用于R-四氢罂粟碱中有关物质的检测。
HPLC method was established for simultaneous determination of 8 related substances in R-tetrahydropapaverine.The C18 packing column was selected according to the compound structure,and the column and chromatographic conditions were screened according to the pharmacopoeia.The results showed that Kromasil 100-5 C18(4.6mm×250mm,5μm)column was used with 10 g/L ammonium formate-acetonitrile(100∶5)as mobile phase A and methanol as mobile phase B.The column temperature was 37℃,the detection wavelength was 280nm,the flow rate was 1.0 mL/min,and the sample size was 10μL.The results showed that the separation degree of 8 related substances in R-tetrahydropapaverine was more than 1.5.The compounds were in the range of 0.5~10.0μg/mL,the correlation coefficient R2≥0.9999,good linearity,strong reproducibility,high sensitivity,and can be used for the detection of related substances in R-tetrahydropapaverine.
作者
杜文哲
徐嘉健
张福利
杨文亮
林丽娅
DU Wenzhe;XU Jiajian;ZHANG Fuli;YANG Wenliang;LIN Liya(School of Chemistry and Chemical Engineering,Shanghai University of Engineering and Science,Shanghai 201620,China;Shanghai Institute of Pharmaceutical Industry Co.,Ltd.,Shanghai 201203,China;Hangzhou Boxiao Bio-Pharmaceutical Co.,Ltd.,Hangzhou 311404,China)
出处
《广州化学》
CAS
2023年第6期75-78,I0004,共5页
Guangzhou Chemistry
