苯磺酸左旋氨氯地平片的RP-HPLC测定及其含量均匀度考察
Determination of content uniformity in levamlodipine besylate tablets by RP-HPLC
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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。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.
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Key words:
- levamlodipine besylate /
- RP-HPLC /
- content uniformity
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