RP-HPLC法测定注射用雷贝拉唑钠有关物质及含量___
RP-HPLC determination of rabeprazole sodium for injection and its related substances
分类号：
出版年·卷·期（页码）：2009,29 (12):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
目的： 建立RP-HPLC法测定注射用雷贝拉唑钠中有关物质及含量的方法。方法： 选用VP-ODS柱（46 mm×250 mm，5 μm），以磷酸盐缓冲液（取磷酸氢二钠1119 g和磷酸二氢钠0179 g，加水1000 mL溶解，混匀）-乙腈（60∶40；用磷酸调pH＝73）为流动相，流速为10 mL·min-1。在286 nm波长处，测定注射用雷贝拉唑钠的有关物质及含量。结果:该方法的线性范围为4787~7181 μg·mL-1（r=099997）,平均回收率（n=9）1008%(RSD=078%),最小检测限为225 ng。结论：本方法测定样品分离效果好，灵敏度高，重现性好，结果准确可靠。
-----英文摘要：---------------------------------------------------------------------------------------
Objective: To establish an RP-HPLC method for determination of rabeprazole sodium for injection and its related substances.Methods:The samples were separated by VP-ODS column（460 mm×250 mm，5 μm）with phosphate buffer solution（add 1119 g of disodium hydrophosphate and 0179 g of sodium bihydrophosphate to 1000 mL of water）-acetonitrile（60∶40 ;adjusted pH to 73 with phosphoric acid）as mobile phase at a flow rate of 10 mL·min-1and detected with UV 286 nm and.Results:The calibration curve was linear in the concentration range of 4787-7181 μg·mL-1(r＝09999)for the content determination;The average recovery （n=9）was 1008%(RSD=078%).The detection limit was 225 ng.Conclusion:The method is good in the aspect of separable effect,reproducibility and sensitivity.
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