HPLC梯度洗脱法测定缩宫素注射液的含量
Content Determination of Oxytocin Injection by HPLC Gradient Elution Method
黎珊珊 1黄子健 1卢瑞芯 1黎芷明 1朱翠娴 1吴映晖 1周小琴1
作者信息
- 1. 广州白云山明兴制药有限公司,广东广州 510250
- 折叠
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® C18(150 mm×4.6 mm,3 μm)色谱柱,检测波长为220 nm;流速为1.0 mL·min1,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pH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pH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·mL-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·mL-1和2.517 9 ng·mL-1;供试品溶液在室温放置24h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.
Abstract
OBJECTIVE To establish an HPLC method for determination of content of oxytocin injection.METHODS An Welch Xtimate® C18(150 mm×4.6 mm,3 μm)column was used with the detection wavelength of 220 nm,and the flow rate of 1.0 mL·min-1,the column temperature was set at 40 ℃.The content determination of oxytocin injection was performed using acetonitrile-water-phosphate solution(0.2 mol·L-1 anhydrous dihydrogen phosphate solution,adjusted the pH 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 pH 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·mL-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·mL-1and 2.517 9 ng·mL-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.
关键词
缩宫素注射液/含量测定/高效液相色谱法Key words
oxytocin injection/content determination/HPLC引用本文复制引用
基金项目
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)
出版年
2024
NETL
NSTL
万方数据