UPLC法同时测定缬沙坦氢氯噻嗪片中缬沙坦和氢氯噻嗪的含量  

Simultaneous Determination of Valsartan and Hydrochlorothiazide in Valsartan Hydrochlorothiazide Tablets by UPLC

作　　者：纪宏[1] 刘晶[1] 王威[1] 祁进[1] 刘清华[1] 

机构地区：[1]北京市药品检验所生命园实验室,北京102206

出　　处：《中国药房》2017年第15期2131-2133,共3页China Pharmacy

摘　　要：目的:建立同时测定缬沙坦氢氯噻嗪片中缬沙坦和氢氯噻嗪含量的方法。方法:采用超高效液相色谱法。色谱柱为Phenomenex C_(18),流动相为[0.1%磷酸溶液-乙腈(95∶5,V/V)]-[0.1%磷酸溶液-乙腈(5∶95,V/V)](梯度洗脱),流速为0.25 mL/min,检测波长为272 nm,柱温为35℃,进样量为1.5μL。结果:缬沙坦和氢氯噻嗪检测质量浓度线性范围分别为8.1~324.2μg/mL(r=0.999 9)、1.2~50.1μg/mL(r=0.999 9);定量限分别为0.24、0.04 ng,检测限分别为0.06、0.01 ng;精密度、稳定性、重复性试验的RSD<2.0%;加样回收率分别为97.69%~100.35%(RSD=1.03%,n=9)、98.27%~100.60%(RSD=0.83%,n=9)。结论:该方法操作简单、快速,结果准确,可用于缬沙坦氢氯噻嗪片中缬沙坦和氢氯噻嗪含量的同时测定。OBJECTIVE： To establish a method for simultaneous determination of valsartan and hydrochlorothiazide in Valsartan hydrochlorothiazide tablets. METHODS： UPLC was adopted. The determination was performed on Phenomenex C18 column with mobile phase consisted of [0.1% phosphoric acid solution-acetonitrile （95： 5, V/V）]-[0.1% phosphoric acid solution-acetonitrile （5 ： 95, V/V）] （gradient elution） at the flow rate of 0.25 mL/min. The detection wavelength was set at 272 nm, and the column tem- peratttre was 35 ℃. The sample size was 1.5μL. RESULTS： The linear range were 8.1-324.2 μg/mL for valsartan （r=0.999 9） and 1.2-50.1 μg/mL for hydrochlorothiazide （r=0.999 9）. The limits of quantitation were 0.24, 0.04 ng, and the limits of detection were 0.06, 0.01 ng. RSDs of precision, stability and reproducibility tests were less than 2.0%; recoveries were 97.69%-100.35% for valsartan （RSD=1.03% ,n=9） and 98.27%-100.60% for hydrochlorothiazide （RSD=0.83% ,n=9）. CONCLUSIONS： The method is simple, rapid and accurate, and can be used for the simultaneous determination of valsartan and hydrochlorothiazide in Valsartan hydrochlorothiazide tablets.

关 键 词：超高效液相色谱法 缬沙坦氢氯噻嗪片 缬沙坦 氢氯噻嗪 含量 

分 类 号：R927.2[医药卫生—药学]