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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(4.6mm×250mm,5μm),以磷酸盐缓冲液(取磷酸氢二钠1.119g和磷酸二氢钠0.179g,加水1000mL溶解,混匀)-乙腈(60∶40;用磷酸调pH=7.3)为流动相,流速为1.0mL·min-1。在286nm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47.87～71.81μg·mL-1(r=0.99997),平均回收率(n=9)100.8%(RSD=0.78%),最小检测限为2.25ng。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。
Objective: To establish a method for the determination of related substances and contents of rabeprazole sodium for injection by RP-HPLC. Methods: VP-ODS column (4.6mm × 250mm, 5μm) was used. Phosphate buffer solution (1.119g of disodium hydrogen phosphate and 0.179g of sodium dihydrogen phosphate dissolved in 1000mL of water) ; Adjusted with phosphoric acid pH = 7.3) as the mobile phase, the flow rate of 1.0mL · min-1. At 286nm wavelength, determination of the substance and content of sodium rabeprazole for injection. Results: The linear range of this method was 47.87 ~ 71.81μg · mL-1 (r = 0.99997). The average recovery was 100.8% (n = 9) with a RSD of 0.78%. The minimum detection limit was 2.25ng. Conclusion: The method has good effect of sample separation, high sensitivity, good reproducibility and accurate and reliable results.