苯磺酸左旋氨氯地平片的RP-HPLC测定及其含量均匀度考察
投稿时间:2001-03-15    点此下载全文
引用本文:刘新宇,吴芳,范国荣,胡晋红.苯磺酸左旋氨氯地平片的RP-HPLC测定及其含量均匀度考察[J].药学实践杂志,2001,(4):222~224
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作者单位
刘新宇 深圳市福田区人民医院药剂科, 深圳518033 
吴芳 第二军医大学附属长海医院药材科, 上海200433 
范国荣 第二军医大学附属长海医院药材科, 上海200433 
胡晋红 第二军医大学附属长海医院药材科, 上海200433 
中文摘要:目的 以尼卡地平为定量内标物,建立反相高效液相色谱法测定苯磺酸左旋氨氯地平片的含量均匀度。方法 色谱柱为Hypersil-ODS2(200mm×40mmID,5μm),流动相为0.02mol/L磷酸二氢钠- 乙腈- 三乙胺(60:40:0.05),检测波长238nm。结果 左旋氨氯地平和内标在6min之内实现理想分离。在1.642~52.56μg/ml范围内左旋氨氯地平与内标峰面积比与其相应浓度呈良好的线性关系(r=0.9999),平均回收率为100.8%,RSD为0.85%。结论 本法操作简便快速,定量准确可靠,可用于苯磺酸左旋氨氯地平含量均匀度的测定。
中文关键词:苯磺酸左旋氨氯地平  反相高效液相色谱法  含量均匀度
 
Determination of content uniformity in levamlodipine besylate tablets by RP-HPLC
Abstract:OBJECTIVE To develop a new RP-HPLC method was established for the determination of content uniformity in levamlodipine besylate tablets with nicadipine as the internal standard by RP HPLC.METHODS The separation was performed on Hypersil ODS 2(200mm×40mmID,5μm)column with 0.02mol/L sodium dihydrogen phosphate acetonitrile triethylamine(60:40:0.05)as mobile phase.The detection wavelength was 238nm.RESULTS Levamlodipine and nicadipine were isolated within 6min.A good linearity was obtained in the range of 1.642~52.56μg/ml(r=0.9999,n=5)for levamlodipine besylate and the average recovery was 100.8% with the RSD of 0.85%.CONCLUSION The method is simple, rapid, accurate,reliable and suitable for the determination of content uniformity in levamlodipine besylate tablets.
keywords:levamlodipine besylate  RP-HPLC  content uniformity
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