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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。
OBJECTIVE: To study the HPLC method of omeprazole sodium and establish HPLC method for the determination of omeprazole sodium for injection. Methods: Kromasil column (C184.6mm × 250mm, 5μ) was used with mobile phase of acetonitrile-phosphate buffer (pH7.3) and triethylamine (22:78:0.7) , UV detection wavelength: 302nm. Results: The linear range of omeprazole sodium was 16.56 ~ 24.84mg.mL-1 (r = 0.9998), the lowest detection limit was 0.1ng, the lowest limit of quantification was 0.4ng, the intraday RSD was 0.31%, and the intraday RSD 0.35%, the relevant impurity separation is good. Conclusion: The proposed method has good precision, accuracy, convenience, rapidity and specificity for omeprazole sodium and its preparation. It is suitable for quality control and finished product inspection in production.