UPLC法同时测定缬沙坦氨氯地平片复方制剂的含量  

Determination of valsartan and amlodipine in compound tablets using UPLC

作　　者：王威[1] 杜晓思 WANG Wei;DU Xiao-si(Beijing Institute for Drug Control,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China)

机构地区：[1]北京市药品检验所,中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《中国新药杂志》2020年第15期1791-1794,共4页Chinese Journal of New Drugs

摘　　要：目的:建立同时测定缬沙坦氨氯地平片中缬沙坦和氨氯地平含量的方法。方法:采用超高效液相色谱法,色谱柱为phenomenex C18柱;流动相为三乙胺缓冲液(取三乙胺10 mL加水至1 L,用磷酸调节pH至2.8)-[甲醇-乙腈(70∶30)](35∶65),流速为0.3 mL·min-1,检测波长237 nm,柱温35℃,进样量1.5μL。结果:缬沙坦和氨氯地平检测质量浓度线性范围分别为32.02~320.22μg·mL-1(r=0.9999)和2.05~20.52μg·mL-1(r=1);定量限分别为0.03和0.02 ng,检测限分别为0.003和0.002 ng;精密度、稳定性、重复性试验的RSD<2.0%;加样回收率分别为99.25%~101.43%(RSD=0.91%,n=9)和97.97%~100.15%(RSD=0.86%,n=9)。结论:该方法操作简单、快速,结果准确,可用于缬沙坦氨氯地平片中缬沙坦和氨氯地平含量的同时测定。Objective:To establish a method for simultaneous determination of valsartan and amlodipine in valsartan-amlodipine compound tablets.Methods:The determination was performed using UPLC on Phenomenex C18 column with mobile phase consisted of triethylamine buffer(water was added to 10 mL triethylamine making final volume of 1 L,pH value was adjusted to 2.8 with phosphoric acid)and methanol-acetonitrile(70∶30,v/v)at the ratio of 35∶65.The flow rate was set at 0.3 mL·min-1,the detection wavelength was 237 nm,the column temperature was 35℃,and the sample size was 1.5μL.Results:The linear range was 32.02~320.22μg·mL^-1(r=0.9999)and 2.05~20.52μg·mL^-1(r=1)for valsartan and amlodipine,respectively.The limits of quantitation were 0.03 ng and 0.02 ng,and the limits of detection were 0.003 ng and 0.002 ng.RSDs of precision,stability and reproducibility tests were less than 2.0%;recoveries were 99.25%~101.43%(RSD=0.91%,n=9)and 97.97%~100.15%(RSD=0.86%,n=9),respectively.Conclusion:The method is simple,rapid and accurate,and can be used for the simultaneous determination of valsartan and amlodipine in valsartan-amlodipine compound tablets.

关 键 词：超高效液相色谱法 缬沙坦氨氯地平片 缬沙坦 氨氯地平 含量 

分 类 号：R932[医药卫生—生药学]