Determination of the contents of drugs and related substances in losartan potassium-hydrochlorothiazide dispersible tablets by HPLC

CHEN Feng-ju1,LI Yan1,LI Jian-wen2,PAN Chang-qi1,LIU Xiao-hong1,HE Zhong-gui1 (1.School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China;2.Sino-Swed Pharmaceutical Corp.Ltd.,Beijing 10005,China)  

Objective To develop a reversed phase high performance liquid chromatography gradient elution method for the determination of the contents and related substances in losartan potassium-hydrochlorothiazide dispersible tablets.Methods The two drugs and suitable adjuvant were mixed to prepare the dispersible tablets.The chromatographic separations were accomplished on C8 column(4.6 mm×150 mm,5 μm)at 40 ℃ with a flow rate of 1.0 mL · min-1,phosphate buffer(pH 7.2)-acetonitrile was used as mobile phase,a gradient elution was performed.The detection wavelength was set at 280 nm.Results The compounds were separated well,the linearities between peak areas and concentrations were observed in the range of 100-600 mg · L-1 for losartan potassium with r=0.999 8,and 25-150 mg · L-1 for hydrochlorothiazide with r=0.999 8.The average recovery was 101.8%and 101.1%,with RSD of 1.8%and 1.3%,respectively.Conclusions The reversed phase high performance liquid chromatography gradient elution method is specific and stable for the determination of the contents and the related substances in losartan potassium-hydrochlorothiazide dispersible tablets.

【Key Words】： losartan potassium hydrochlorothiazide dispersible tablet content determination related substance HPLC
【CateGory Index】： R927.2
【DOI】： CNKI:SUN:SYYD.0.2009-06-010

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