Content Determination of Aflatoxin G 2,G1,B2 and B 1 in Qinghuo Tablets (Capsules)by HPLC-post-column Photochemical Derivatization and Its Safety Evaluation
- VernacularTitle:HPLC-柱后光化学衍生法测定清火片(胶囊)中黄曲霉毒素G2、G1、B2、B1的含量及其安全性评价
- Author:
Yunxia WANG
1
;
Juan WANG
1
;
Zhimin XIE
1
Author Information
1. Xi’an Institute for Food and Drug Control,Xi’an 710054,China
- Publication Type:Journal Article
- Keywords:
Aflatoxin;
Qinghuo tablets;
Qinghuo capsules;
HPLC-post-column photochemical derivatization
- From:
China Pharmacy
2019;30(7):906-909
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE: To establish a method for content determination of aflatoxin (AF) G2, G1, B2 and B1 in Qinghuo tablets (capsules), and to evaluate the safety of the preparation. METHODS: HPLC-post-column photochemical derivatization was adopted, and 266 batches of Qinghuo tablets (capsules) from 37 manufacturers as sample. The determination was performed on Agilent C18 column with mobile phase consisted of water-acetonitrile-methanol (V/V/V, gradient elution) at the flow rate of 1.0 mL/min. The column temperature was set at 40 ℃. Excitation wavelength and emission wavelength of fluorescence detector were 360 and 450 nm. RESULTS: The linear ranges of AF G2, AF G1, AF B2 and AF B1 were 10.197-101.97 (r=0.999 7), 10.197-101.97 (r=0.999 6), 9.958 6-99.586 (r=0.999 1), 9.999 0-99.990 (r=0.998 3) pg, respectively. RSDs of precision (n=6), reproducibility (n=6) and stability tests (12 h, n=5) were all lower than 3.0%. The detection limits were 0.80, 4.00, 0.80 and 4.00 pg, respectively. The quantitation limits were 1.60, 8.00, 1.60 and 8.00 pg, respectively. The recoveries were 85%-90%, 85%-90%, 55%-65%, 65%-75% (RSD=1.8%-4.7%, n=6). AF G2, AF G1, AF B2 and AF B1 were not detected in 266 batches of samples. CONCLUSIONS: This method is suitable for the determination of AF in Qinghuo tablets (capsules). Although AF was not detected in the sample, it is advisable to add the determination of AF so as to improve its safety.