Simultaneous Determination of Valsartan and Hydrochlorothiazide in Valsartan Hydrochlorothiazide Tab-lets by UPLC / 中国药房

ABSTRACT

OBJECTIVE:To establish a method for simultaneous determination of valsartan and hydrochlorothiazide in Valsar-tan 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-perature was 35 ℃. The sample size was 1.5 μL. RESULTS:The linear range were 8.1-324.2 μg/mL for valsartan(r=0.9999)and 1.2-50.1 μg/mL for hydrochlorothiazide(r=0.9999). 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.