| 陈承贵,李美芳,庞发根,李玉兰,王铁杰.国产地氯雷他定片溶出度方法的建立[J].中国药品标准,2018,19(6):437-441 |
| 国产地氯雷他定片溶出度方法的建立 |
| Establishment of Dissolution test of Domestic Desloratadine Tablets |
| 投稿时间：2018-04-25 修订日期：2018-11-30 |
| DOI： |
| 中文关键词: 地氯雷他定片 溶出度 高效液相色谱法 |
| 英文关键词: Desloratadine tablets Dissolution High Performance Liquid Chromatography |
| 基金项目: |
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| 中文摘要: |
| 目的： 建立有效区分地氯雷他定片质量并具有国际通用性的溶出度HPLC测定方法。 方法：采用桨法,以0.1 mol.L-1盐酸溶液为溶出介质,转速50 r.min-1,采用高效液相色谱法测定溶出度,以辛烷基硅烷键合硅胶为填充剂,流动相为甲醇-0.5%三氟醋酸溶液(用三乙胺调pH值至6.3)(55:45),流速：1.0ml.min-1,柱温：30℃,检测波长247 nm。结果：地氯雷他定在1.02~204.20μg.mL-1的浓度范围内,线性关系良好(r=1),平均回收率为100.5%,RSD为0.3%(n=9),国内片剂在30min时的溶出度均在95%以上。结论：本方法准确、简单方便且高效,测定结果均一性良好,可有效地用于地氯雷他定片溶出度的测定。 |
| 英文摘要: |
| Objective：To establish an effective method for determining the quality of domestic desloratadine tablets and the dissolution determination of HPLC with international universality. Methods：The paddle method was adopted with 0.1 mol.L-1 hydrochloric acid as solvent at rotation speed of 50 r.min-1. HPLC was adopted to determine the dissolution rates of domestic desloratadine tablets using an octane silicane bonded silica gel as filler with isocratic elution system of methanol-0.5% trifluoroacetic acid(with triethylamine adjust pH value to 6.3)(55:45),while the column temperature was maintained at 30℃, the flow rate was 1.0ml/min and the detection wavelength was 247nm. Results：Desloratadine showed a good linear relationship within the range of 1.02~204.20 μg.mL-1(r=1), the average recovery was 100.5%, with RSD was 0.3%(n=9), the dissolution rate of domestic desloratadine tablets were all above 95% at 30min. Conclusion：The method is accurate , sample, convenient and efficient. The results were homogenous, and can be used in the dissolution determination of domestic desloratadine tablets. |
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