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

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.