苯磺酸氨氯地平片的质量控制研究

目的:针对苯磺酸氨氯地平有显著降压效果,建立苯磺酸氨氯地平片的质量控制研究,为复方质量控制标准提供依据。方法:采用高效液相色谱(HPLC)法测定苯磺酸氨氯地平的含量。色谱柱:Phenomenex C18柱(200 mm×4.6 mm,5μm);流动相:0.03 mol.L-1KH2PO4-甲醇(25∶75);检测波长:237 nm;流速:1 mL.min-1;柱温:室温。采用浆法测定溶出度,并计算累计溶出百分率。结果:苯磺酸氨氯地平在10～70μg.mL-1的浓度范围内与峰面积线形良好,线性回归方程为:Y=18 914 X+13 640,相关系数为r=0.999 3;平均回收率为100.65%,RSD为0.99%;溶出时间为30 min时累积释放百分率达80%,符合《中华人民共和国药典》规定。结论:各项检验方法简便、准确、可靠,可作为该制剂的质量控制方法。

Quality Control of Amlodipine Besylate Tablet

OBJECTIVE: To establish the study on the quality control of amlodipine besylate tablet in view of its remarkable antihypertensive efficacy so as to provide basis for the quality control of the preparation.METHODS: HPLC was employed for content determination of amlodipine besylate tablet with Phenomenex-C18 column(200 mm×4.6 mm,5 μm) at room temperature.The mobile phase consisted of 0.03 mol·L-1 KH2PO4-methanol solution(25∶75) at a flow rate of 1 mL·min-1 with the detecting wavelength set at 237 nm.The dissolution was determined by oar spectrometry with cumulative dissolution percentage computed.RESULTS: Amlodipine besylate has a good linear relationship at a concentration range of 10-70 μg·mL-1,with the standard curve equation Y=18 914 X+13 640(r=0.999 3),the average recoveries of 100.65%,RSD of 0.99%,and cumulative dissolution percentage of 80% at 30 min(dissolution time) which was in line with the standard of Pharmacopoeia of the People’s Republic of China.CONCLUSION: Each determination method is simple,accurate and reliable and which can be used as the quality control method of amlodipine besylate tablet.