Determination of taursodeoxycholic acid and taurchenodeoxycholic acid in Longze Xiongdan capsules by HPLC-ELSD
10.19778/j.chp.2024.01.013
- VernacularTitle:HPLC-ELSD法测定龙泽熊胆胶囊中牛磺熊去氧胆酸和牛磺鹅去氧胆酸的含量
- Author:
QIAO Li
;
CHEN Zhengdong
;
CHEN Fu
;
JIAN Shuyi
;
HUANG Junzhong
;
HUANG Youwen
;
LIU Xiaoxiao
- Publication Type:Journal Article
- Keywords:
HPLC-ELSD;
Longze Xiongdan capsules;
bear bile powder;
taursodeoxycholic acid;
taurchenodeoxycholic acid
- From:
Drug Standards of China
2024;25(1):076-081
- CountryChina
- Language:Chinese
-
Abstract:
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 gradient 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 presented 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.
- Full text:202408101323228076220240213.pdf
