| 周临,罗荣.奥美拉唑胶囊剂有关物质再评价[J].实用中西医结合临床,2022,22(13): |
| 奥美拉唑胶囊剂有关物质再评价 |
| Re-evaluation of related substances in omeprazole capsules |
| 投稿时间：2022-08-08 修订日期：2022-09-02 |
| DOI： |
| 中文关键词: 奥美拉唑 校正因子 有关物质 肠溶胶囊 |
| 英文关键词: omeprazole the related substances the correction factor |
| 基金项目: |
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| 中文摘要: |
| [摘要] 目的：建立合适的高效液相色谱法检测奥美拉唑肠溶胶囊中的有关物质的含量。方法：phenomenex luna C8色谱柱（150mm×4.6mm，5μm），流动相为乙腈：0.01M磷酸氢二钠溶液（用磷酸调节pH至7.6）（25:75），检测波长为280nm，流速为1.0mL/min，柱温为30℃。结果：该色谱条件能有效检出奥美拉唑肠溶胶囊中的降解产物，检测限为1ng（0.025%）。结论：该方法简便、可靠、快速，能够准确测量奥美拉唑肠溶胶囊中有关物质的含量。 |
| 英文摘要: |
| [Abstract］Objective: To establish an appropriate HPLC method to determine related substances in Omeprazole Enteric-coated Capsules. Method: Chromatography was carried out by reversed-phase technique on an phenomenex luna C8 column ( 4. 6 mm×150mm，5μm) with a mobile phase composed of 0. 01 mol/L disodium hydrogen phosphate ( adjusted to pH 7. 6 with phosphate acid ) and acetonitrile in the ratio of ( 75:25) pumped at a flow-rate of 1. 0 mL/min． The detection was carried out at 280 nm and a column temperature of 30℃．Result: The related substances could be determined by HPLC. The detection limit was 1ng(0.025%) . Conclusion: The method was simple，efficient and accurate for analyzing the related substances in Omeprazole enteric-coated Capsules． |
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