Simultaneous determination of six components in Shangke Dieda Tablets by UPLC
10.19778/j.chp.2024.04.007
- VernacularTitle:UPLC同时测定伤科跌打片中6种有效成分的含量
- Author:
Jinmiao TIAN
1
;
Junshuai LI
;
Xiaoyue WANG
;
Xueting TANG
;
Aiping HE
;
Chunling ZHOU
Author Information
1. 辽宁省检验检测认证中心-辽宁省药品检验检测院,沈阳 110036
- Keywords:
UPLC;
Shangke Dieda Tablets;
paeoniflorin;
naringin;
hesperidin;
neohesperidin;
costunolide;
dehydrocostuslactone;
content determination
- From:
Drug Standards of China
2024;25(4):366-371
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a UPLC method for the simultaneous determination of paeoniflorin,naringin,hesperidin,neohesperidin,costunolide and dehydrocostuslactone to improve the quality standard of Shangke Dieda Tablets.Methods:An Agilent Poroshell 120 C18 column(100 mm × 4.6 mm;2.7 μm)was used with a mobile phase of acetonitrile and 0.1％phosphate solution with binary gradient system at a flow rate of 1.0 mL·min-1.The detection wavelength was 230 nm and the column temperature was 30 ℃.Results:Paeoniflorin,naringin,hesperidin,neohesperidin,cosinolide and dehydrocosinolide showed a good linear relationship between injection concentration and peak area(r＞0.999).The linear ranges of six components were 0.854 2-256.272 μg·mL-1(r=0.999 9),1.057 5-317.247 μg·mL-1(r=0.999 9),and 0.989 5-269.850 μg·mL-1(r=0.999 9),1.055 6-316.689 μg·mL-1(r=0.999 9),0.905 1-271.527 μg·mL-1(r=0.999 8),and 1.064 7-319.395 μg·mL-1(r=0.999 9),respectively.The average recoveries of six components were 99.4％(RSD=1.2％),104.0％(RSD=1.2％),101.6％(RSD=1.0％),102.9％(RSD=0.4％),97.0％(RSD=1.9％),and 104.2％(RSD=1.0％),respectively.A total of 74 batches of samples were collected from 10 manufacturers.The contents of paeoniflorin,naringin,hesperidin,neohesperidin,coxinolactone,and dehydro-cosinolactone were 0.250 8-0.653 2,0.042 2-0.930 9,0.590 9-3.978 0,0.021 2-0.592 6,0.002 4-0.156 7,0.009 2-0.231 3 mg per tablet,respectively.Conclusion:The validated results showed that the method can be used to control the quality of Shangke Dieda Tablets.
