摘要
目的 建立缩宫素注射液含量的高效液相色谱方法 。方法 采用Welch Xtimate^®C_(18)(150 mm×4.6 mm,3μm)色谱柱,检测波长为220 nm;流速为1.0 m L·min^(-1),柱温为40℃。以乙腈-水-缓冲盐溶液(0.2 mol·L^(-1)无水磷酸二氢钠,用氢氧化钠调p H值至6.2,15∶70∶15)为流动相A,以乙腈-水-缓冲盐溶液(0.2 mol·L^(-1)无水磷酸二氢钠,用氢氧化钠调p H值至6.2,70∶15∶15)为流动相B,采用梯度洗脱。结果 空白溶剂和空白辅料溶液对缩宫素的测定无干扰;缩宫素的线性范围为2.007 8~20.077 8 IU·m L^(-1)(r=0.999 9);平均回收率为98.54%(RSD为1.34%);缩宫素的定量限及检测限分别为8.393 0 ng·m L^(-1)和2.517 9 ng·m L^(-1);供试品溶液在室温放置24 h稳定。结论 本方法 准确、简便、可靠,可用于缩宫素注射液的含量测定。
OBJECTIVE To establish an HPLC method for determination of content of oxytocin injection.METHODS An Welch Xtimate^®C_(18) (150 mm×4.6 mm,3μm) column was used with the detection wavelength of 220 nm,and the flow rate of 1.0 m L·min^(-1),the column temperature was set at 40℃.The content determination of oxytocin injection was performed using acetonitrile-waterphosphate solution (0.2 mol·L^(-1) anhydrous dihydrogen phosphate solution,adjusted the p H value to 6.2 with sodium hydroxide solution,15∶70∶15) as mobile phase A,acetonitrile-water-phosphate solution (0.2 mol·L^(-1) anhydrous dihydrogen phosphate solution,adjusted the p H value to 6.2 with sodium hydroxide solution,70∶15∶15) as mobile phase B.Gradient elution was used.RESULTS Blank solvent and blank excipient solution did not interfere with the determination of oxytocin.The linear ranges of the content of oxytocin injection was 2.007 8-20.077 8 IU·m L^(-1) (r=0.999 9),the average recovery was 98.54%(RSD of 1.34%).The quantification limit and detection limit were 8.393 0 ng·m L^(-1 )and 2.517 9 ng·m L^(-1).The test solution was stable at room temperature within 24 h.CONCLUSION The method is accurate,simple,reliable,and can be used for the determination of the content in oxytocin injection.
作者
黎珊珊
黄子健
卢瑞芯
黎芷明
朱翠娴
吴映晖
周小琴
LI Shanshan;HUANG Zijian;LU Ruixin;LI Zhiming;ZHU Cuixian;WU Yinghui;ZHOU Xiaoqin(Guangzhou Baiyunshan Mingxing Pharmaceutical Co.,Ltd.,Guangzhou,Guangdong 510250,China)
出处
《今日药学》
CAS
2024年第7期513-516,共4页
Pharmacy Today
基金
国家工信部华南地区小品种药品集中供应保障能力建设重点项目(TC18086KV)。