Simultaneous Determination of 4 Components in Regan Saibisitan Granules by RP-HPLC / 中国药房

ABSTRACT

OBJECTIVE:To establish the method for simultaneous determination of gallic acid,rosmarinic acid,liquiritin and ammonium glycyrrhetate in Regan saibisitan granules. METHODS:RP-HPLC method was adopted. The determination was per-formed on Waters RP-C18 column with mobile phase consisted of acetonitrile-0.2% phosphoric acid (gradient elution) at the flow rate of 1.0 mL/min. The detection wavelengths were 210 nm(gallic acid,rosmarinic acid and liquiritin),230 nm(ammonium glyc-yrrhetate). The column temperature was 28 ℃,and sample size was 20 μL. RESULTS:The linear ranges were 0.2744-7.546 μg for gallic acid(r=0.9998),0.1870-5.143 μg for rosmarinic acid(r=0.9996),0.1300-3.575 μg for liquiritin(r=0.9999)and 0.2540-6.985μg for ammonium glycyrrhetate(r=0.9998),respectively. The LOQ were 2.67,1.36,1.09 and 2.11 ng,respective-ly. The LOD were 1.03,0.62,0.87 and 0.91 ng,respectively. RSDs of precision,stability and repeatability tests were all less than 2.0%. The average recoveries were 97.26%-101.00%(RSD=1.1%,n=9),97.66%-101.80%(RSD=1.3%,n=9),97.45%-101.70%(RSD=1.4%,n=9),97.74%-101.70%(RSD=1.4%,n=9). CONCLUSIONS:The method is simple,accurate and reproducible, and can be applied for simultaneous determination of gallic acid,rosmarinic acid,liquiritin and ammonium glycyrrhetate in Regan saibisitan granules.