中国药业2011，Vol.20Issue(15)：23-24,2.
苯磺酸氨氯地平片的有关物质检查方法研究
Examination of Related Substances in Amlodipine Bensylate Tables by RP - HPLC with Ultraviolet Detection
摘要
Abstract
Objective To establish a reversed - phase high performance liquid chromatography for the examination of related substances in Amlodipine Bensylate Tablets. Methods A specific and stable RP - HPLC with ultraviolet detection was employed. The chromatography was accomplished on Diamonsil C18 column (200 mm ×4. 6 mm,5 μm) and the mobile phase consisted of methanol - 30mmol/L potassium dihydrogen phosphate acid(60 ∶ 40),the flow rate was 1. 0 mL/min,detection wave length was set at 238 nm and the column temperature was maintained at room temperature. Results All the related substances gained a completely chromatographic separation with the principal peak. A good relationship was observed in the concentration range of 0. 71 - 3. 57 μg/mL, with the correlation coefficient of 0. 999 7. Conclusion The method was proved to be highly specific , accurate and sensitive. It can be applied for the examination of the related substances in amlodipine besylate.关键词
高效液相色谱法/苯磺酸氨氯地平片/有关物质Key words
HPLC/ Amlodipine Besylate Tables/ related substance分类
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秦书德,马晓伟,陈静,郭兴杰..苯磺酸氨氯地平片的有关物质检查方法研究[J].中国药业,2011,20(15):23-24,2.
