HPLC法测定苯磺酸氨氯地平口服制剂的含量及含量均匀度Study on Content and Its Uniformity of Oral Solid Preparations of Amlodipine Besylate by HPLC
孔爱英,巩芳,樊春艳,邱英麒
KONG Aiying,GONG Fang,FAN Chunyan,QIU Yingqi
摘要(Abstract)：
目的建立磺酸氨氯地平片、分散片、胶囊、滴丸四种口服固体制剂中氨氯地平的含量及含量均匀度的一致分析方法。方法采用C18色谱柱,流动相:乙腈-甲醇-三乙胺溶液(p H值3.0)=15∶35∶50;流速:1.0 m L/min,柱温:30℃,检测波长为237nm。结果磺酸氨氯地平浓度在1.0~200.0 g/m L范围内,与其峰面积呈良好线性关系,回归方程为:A=55 952C+10 573(A:峰面积;C:g/m L,r=1.0)。磺酸氨氯地平溶液在48 h内稳定,精密度良好,片、分散片、胶囊、滴丸4种口服剂型的平均回收率分别为99.0%(RSD=0.6%)、100.2%(RSD=1.2%)、101.2%(RSD=0.4%),100.1%(RSD=0.4%)(n=9)。结论建立的方法准确、简便、易行,可用于4种口服固体制剂的质量控制。
OBJECTIVE To establish an HPLC method for determining content and its uniformity of 4 preparations of am Lodipine besylate. METHODS The C18 column was adopted with UV detection wavelength of 237 nm. The mobile phase consisted of acetonitrile-methanol- triethylamine( p H = 3.0)( 15 ∶ 35 ∶ 50). The flow rate was 1.0 m L / min,and the column temperature was 30 ℃.RESULTS The calibrated linear curve of amlodipine besylate was within 1.0- 200.0 μg / m L( r = 1.0,n = 5). The average recovery rates of tablets,dispersible tablets,capsules and drop pills were 99. 0%( RSD = 0. 6%),100. 2%( RSD = 1. 2%),101. 2%( RSD =0. 4%),100.1%( RSD = 0. 4%)( n = 9),respectively. The reproducibility and precision of the method were good( RSD < 1%).CONCLUSION This method is accurate,simple and fast,which is suitable for the quality control of Amlodipine Besylate of 4 oral solid preparations.
关键词(KeyWords)：
苯磺酸氨氯地平;含量测定;高效液相色谱法;口服固体制剂
amlodipine besylate;content;HPLC;oral solid preparations
基金项目(Foundation): 氨氯地平质量标准提高计划2012年国家药典委员会项目(No.1217~1228)
作者(Author):
孔爱英,巩芳,樊春艳,邱英麒
KONG Aiying,GONG Fang,FAN Chunyan,QIU Yingqi