注射用奥美拉唑钠HPLC含量测定方法研究

目的:对奥美拉唑钠的HPLC分析方法进行研究,建立注射用奥美拉唑钠含量的HPLC分析方法。方法:采用kromasil色谱柱(C184.6mm×250mm,5μ),以乙腈-磷酸盐缓冲液(pH7.3)-三乙胺(22∶78∶0.7)为流动相,流速1.0mL.min-1,紫外检测波长:302nm。结果:奥美拉唑钠在16.56～24.84mg.mL-1范围内线性关系良好(r=0.9998),最低检测限为0.1ng,最低定量限为0.4ng,日内RSD为0.31%,日间RSD为0.35%,相关杂质分离度良好。结论:该方法对奥美拉唑钠及其粉针制剂含量测定精密度良好、准确、方便、快速、专属性强,适合生产中对质量的控制和成品的检验工作。

Determination of HPLC Content Omeprazole Sodium for Injection

Objective：To develop a HPLC method for Omeprazole sodium assay and establish a HPLC method for determination of Omeprazole sodium for injection. Methods： Chromatographic conditions included a KromasibC18 Column （4.6mm × 250mm, 5μ）, a mobile phase of Acetonitrile-Phosphate buffer（pH7.3）-Triethylamine （22：78：0.7） with a flow rate of 1.0mL · min^-1 and a UV de- tector at 302nm. Results： A linear range of determination of 16.56-24.84mg · mL^-1 （r= 0. 9998）was obtained. The Limit of detec- tion （LOD） was 0. lng and Limit of quantitation （LOQ） was 0.4ng. The intra-day precision RSD was 0.31 % and inter-day precision RSD was 0.35 %. There is a good resolution between Omeprazole sodium peak and other peaks. Conclusion：a precise , accurate, simple, fast and specific HPLC method for determination of Omeprazole sodium and Omeprazole sodium for injection was estab- lished. The method developed is well suited for the assay and quality control.