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目的研究反相高效液相色谱法测定奥美拉唑镁肠溶片中有效成分的含量。方法采用Diamon-sil C18柱(4.6mm×250mm,5μm);以甲醇-水-磷酸-三乙胺(70:30:0.12:0.3)为流动相,流速1.0ml/min,检测波长302nm,进量样20μl。结果奥美拉唑镁浓度在4～36μg/ml范围内,与峰面积呈良好的线性关系,r=1.0000(n=5);最低检测浓度为0.5μg.ml-1;平均回收率为100.7%,RSD为0.27%(n=9);奥美拉唑镁主峰与杂质峰能分离。结论采用反相高效液相色谱法测定奥美拉唑镁肠溶片的含量,方法简便,结果准确,专属性强,适用于奥美拉唑镁片剂的质量评价。
Objective To study the determination of active ingredients in omeprazole magnesium enteric-coated tablets by reversed-phase high performance liquid chromatography. Methods Diamon-sil C18 column (4.6mm × 250mm, 5μm) was used. The mobile phase was methanol-water-phosphoric acid-triethylamine (70: 30: 0.12: 0.3) Amount of sample 20μl. Results The concentration of omeprazole magnesium in the range of 4 ~ 36μg / ml showed a good linear relationship with the peak area, r = 1.0000 (n = 5); the lowest detection concentration was 0.5μg.ml-1; the average recovery was 100.7 %, RSD was 0.27% (n = 9). The main peak of omeprazole magnesium and impurity peak could be separated. Conclusion The determination of omeprazole magnesium enteric-coated tablets by reversed-phase high performance liquid chromatography has the advantages of simple and convenient method, accurate results and high specificity, and is suitable for the quality evaluation of omeprazole magnesium tablets.