Content Determination of Three Components in Gandan Shuangqing Oral Liquid
Objective To establish a high-performance liquid chromatography(HPLC)method for the content determination of tauroursodeoxycholic acid,taurochenodeoxycholic acid,and specnuezhenide in Gandan Shuangqing Oral Liquid.Methods For the content determination of tauroursodeoxycholic acid and taurochenodeoxycholic acid,the chromatographic column was Agilent Extend-C18 column(150 mm×4.6 mm,3.5 mm),the mobile phase was 0.02 mol/L sodium dihydrogen phosphate aqueous solution(pH was to adjusted 6.0 with triethylamine)-acetonitrile(gradient elution),the flow rate was 1 mL/min,the detection wavelength was 205 nm,the column temperature was 40℃,and the injection volume was 10 µL.For the content determination of specnuezhenide,the chromatographic column was Thermo AcclaimTM 120A C18 column(250 mm×4.6 mm,5 mm),the mobile phase was acetonitrile-water(gradient elution),the flow rate was 1 mL/min,the detection wavelength was 224 nm,the column temperature was 40℃,and the injection volume was 10 µL.Results The linear ranges of tauroursodeoxycholic acid,aurochenodeoxycholic acid,and specnuezhenide were 0.040 0-1.000 5 mg/mL,0.031 0-0.776 0 mg/mL,and 0.029 3-0.731 5 mg/mL(r=0.999 9,n=6).The RSDs of precision,stability,and repeatability test results were all lower than 2.0%(n=6).The average recoveries of tauroursodeoxycholic acid,aurochenodeoxycholic acid,and specnuezhenide were 98.49%,99.49%,99.78%,with RSDsof 3.04%,2.20%,and 1.15%(n=6),respectively.The contents of three components in the three batches of samples were in the ranges of 0.323 1-0.325 8 mg/mL,0.285 8-0.287 6 mg/mL,and 0.268 8-0.305 5 mg/mL,respectively.Conclusion The established method is simple,quick,reproducible,and accurate,which can be used for the content determination of tauroursodeoxycholic acid,taurochenodeoxycholic acid,and specnuezhenide in Gandan Shuangqing Oral Liquid.