| 磺胺嘧啶银乳膏含量测定方法的优化和极端环境下的稳定性考察 |
| 投稿时间：2020-12-28 修订日期：2021-02-25 点此下载全文 |
| 引用本文：李玲,宋洪杰,丁德英,舒丽芯.磺胺嘧啶银乳膏含量测定方法的优化和极端环境下的稳定性考察[J].药学实践杂志,2021,39(4):345~347,368 |
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| 中文摘要:目的 优化磺胺嘧啶银乳膏中磺胺嘧啶银的含量测定方法，并考察其在高温、高湿、高盐环境下的稳定性。方法 采用反相高效液相色谱法，选用Agilent ZORBAX SB-C18色谱柱(4.6 mm×150 mm，5 μm)，流动相：乙腈-0.1％磷酸(8∶92，V/V)，流速1.0 ml/min，柱温30 ℃，检测波长254 nm。采用复合式盐雾试验箱模拟高温、高湿、高盐环境，考察0、2、4、6、8、10、12周磺胺嘧啶银含量变化情况。结果 磺胺嘧啶银在4.00～20.00 μg/ml范围内与峰面积呈良好的线性关系(r=0.999 9)，平均回收率为101.47% (RSD=2.33%)。含量测定结果显示，磺胺嘧啶银乳膏在4周以后含量开始显著下降。结论 该方法简便、准确、可靠，可用于磺胺嘧啶银乳膏中磺胺嘧啶银的含量测定。测定结果表明，磺胺嘧啶银乳膏在高温、高湿、高盐环境下不稳定，在其运输、储存和使用过程中应充分考虑环境的影响，执行长远航任务时应考虑对其外包装增加防护措施，或更换具有类似药效作用的其他品种。 |
| 中文关键词:磺胺嘧啶银 含量测定 稳定性 高效液相色谱法 |
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| Optimization of determination method for silver sulfadiazine cream and its stability under extreme conditions |
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| Abstract:Objective To optimize the method of assay for silver sulfadiazine, and to investigate its stability in high temperature, humidity and salt environment.Methods Agilent ZORBAX SB-C18 column was used in HPLC for the determination of silver sulfadiazine with acetonitrile and 0.1% phosphoric acid as mobile phase.The flowing rate was 1.0 ml/min and column temperature was 30℃. Salt spray test chamber was used to simulate the high temperature, humidity and salt environment. The silver sulfadiazine content was assayed at 0, 2, 4, 6, 8, 10, 12 weeks.Results The calibration curve was linear within the range of 4.00～20.00 μg/ml (r=0.9999). The average recovery was 101.47% (RSD=2.33%). The content of silver sulfadiazine cream began to decrease significantly after 4 weeks.Conclusion This method is convenient, accurate and reliable. It can be used for the content determination of silver sulfadiazine in the cream.The results showed that the silver sulfadiazine cream was unstable in the environment of high temperature, humidity and salt. Therefore, environmental impact should be fully considered in transportation, storage and application. For the long-distance navigation mission, protective measures should be taken for its packaging or replace it with more stable products. |
| keywords:silver sulfadiazine content determination stability HPLC |
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