HPLC法同时测定苯磺酸氨氯地平片中7个杂质的含量

Simultaneous Determination of Seven Impurities in Amlodipine Besylate Tablets by HPLC

建立了HPLC法同时检测苯磺酸氨氯地平中7个杂质的检测方法,该法采用0.1%磷酸溶液(氨水调节pH3.5)-甲醇-乙腈体系进行梯度洗脱,没有使用ChP2015和USP41中有腐蚀性的三乙胺缓冲体系,有效地减少了基线噪音和对色谱柱的损害,同时该缓冲盐体系为离子抑制色谱,与EP9.0的乙酸铵体系相比大大提高了方法的耐用性,洗脱梯度的设计避免了有机相浓度过高导致缓冲盐析出。在该方法下,苯磺酸氨氯地平和其7个杂质均能达到有效分离,且方法专属性、灵敏度、特别耐用性较好,明显优于EP9.0、ChP2015、USP41、JP17等药典的方法。

A method has been developed for determination of seven impurities in amlodipine tablets by HPLC. The gradient elution method used 0.1% phosphoric acid solution (adjusting pH to 3.5 by ammonia water)- methanol-acetonitrile as mobile phase without triethylamine. Design of elution gradient avoided buffer salt precipitation due to excessive concentration of organic component. Under the chromatographic conditions, amlodipine besylate and its seven impurities were effectively separated. The method showed high specificity, robustness and sensitivity. The new method is obviously better than those methods published in EP9.0, ChP2015, USP41, JP17 and other related literature.