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目的建立一种有效地分析方法,对注射用埃索美拉唑钠中的光学异构体进行控制。方法采用手性色谱柱(以α1-酸性糖蛋白键合硅胶为填充剂);以乙腈—磷酸盐缓冲液(p H 6.2)(9∶91)为流动相;流速为0.9ml/min;检测波长为302nm。进行了方法学验证:异构体之间分离度为5.2;线性回归方程为:Y=50.91X-0.52,R2=0.999;平均加样回收率为100.46%。经验证确定了此方法的可行性,并对研制样品中光学异构体含量有效的进行了控制。结果分离度测试溶液色谱图中,2种方法左旋奥美拉唑与右旋奥美拉唑的分离度均>2.5,但方法一柱效不佳,峰型较差;方法二柱效、峰型均比较好。结论手性色谱柱方法准确,灵敏,专属性和重现性良好,能够对研制样品注射用埃索美拉唑钠的光学异构体含量进行有效的控制。
Objective To establish an effective analytical method for the control of optical isomers in esomeprazole sodium for injection. Methods Chiral column (α1-acidic glycoprotein bonded silica gel as a filler), acetonitrile-phosphate buffer (pH 6.2) (9:91) was used as the mobile phase at a flow rate of 0.9 ml / min. The wavelength is 302nm. The methodological verification was carried out: the resolution between isomers was 5.2; the linear regression equation was: Y = 50.91X-0.52, R2 = 0.999; the average recovery rate was 100.46%. The feasibility of this method has been confirmed and the control of the content of optical isomers in the developed samples has been carried out. Results of the resolution test solution chromatograms, the two methods of levorphanol and dextro-omeprazole resolution> 2.5, but the method of a poor column efficiency, poor peak shape; method two column effect, peak Type are better. Conclusion The chiral column method is accurate, sensitive, specific and reproducible. It can effectively control the optical isomer content of esomeprazole sodium for injection.