Determination of taursodeoxycholic acid and taurchenodeoxycholic acid in Longze Xiongdan capsules by HPLC-ELSD
Objective:To establish a method for determining the content of bear bile powder in Longze Xiongdan capsules with taursodeoxycholic acid(TUDCA)and taurchenodeoxycholic acid(TCDCA)as indexes.Methods:HPLC series evaporation photodetector was adopted on Chrom Core AQ C18 column(4.6 mm ×250 mm,5 μm),with the mobile phase comprising of acetonitrile(A)and 5 mmol·L-1 ammonium acetate solution(B)in a gra-dient elution(0-40 min,25%A;40-50 min,25%A→29%A;50-80 min,29%A;80-100 min,29%A→40%A)at the flow rate of 1.0 mL·min-1:The column temperature was 30 ℃.The ELSD was used,of which the drift tube temperature was 110 ℃ and the flow rate of carrier gas(N2)was 2.5 L·min-1.Results:In the ranges of 1.069-9.57 μg and 0.740 46-7.404 64 μg,logarithms of the injected amount of TUDCA and TCDCA pres-ented good linear relationships with logarithms of the peak area,respectively.The RSDs of precision,repeatability and stability tests were all lower than 2.0%.At three concentration levels the recoveries of TUDCA and TCDCA were 95.2%-97.7%and 91.9%-95.9%,respectively.Samples of 42 batches showed that the contents of TUDCA and TCDCA were 0.18-0.43 and 0.10-0.44 mg·granule-1,respectively.Conclusion:This method can be used for the quality control of bear bile powder in Longze Xiongdan capsules,thus provides a scientific basis for improving its quality standard.
HPLC-ELSDLongze Xiongdan capsulesbear bile powdertaursodeoxycholic acidtaurchenodeoxy-cholic acid