摘要
目的建立测定硝酸一叶萩碱注射液的有关物质及含量测定的高效液相色谱法。方法色谱柱VP-ODS,流动相为甲醇-40mmol.L-1乙酸铵溶液（45∶55）,流速1.0 mL.min-1,检测波长256nm。结果一叶萩碱经强酸、强碱、高温、氧化等剧烈条件破坏,所产生的降解产物峰与一叶萩碱峰能很好地分离。在3.2~3200μg.mL-1浓度范围内具有良好的线性关系,r=0.9999（n=7）。含量测定平均回收率为99.0%（n=9）,RSD为0.5%。结论该方法可用于硝酸一叶萩碱注射液的质量控制。
Objective To establish a HPLC method for determination of related substances and assay of Securinine Nitrate Injection. Methods The separation was performed on a VP-ODS column with a mobile phase of methanol-40mmol · L^-1 ammonium acetate solution （45 ： 55）. The flow rate was 1.0mL · min^-1 , and the detecting wavelength was 256nm. Results The degradation peaks produced by destroying securinine with strong acid, alkali, high temperature and oxidation respectively could be well separated from that of securinine by this method. The linear range was 3.2-3200μg · mL^-1, r= 0. 9999 （n=7）. The mean recovery of the assay was 99.0%（n=9） and RSD was 0. 5%. Conclusions The method can be used in the quality control of securinine nitrate injection.
出处
《中国药事》
CAS
2009年第9期917-919,共3页
Chinese Pharmaceutical Affairs
