Limit test for 5-hydroxymethylfurfural in Yueju Baohe pills
10.19778/j.chp.2024.01.009
- VernacularTitle:越鞠保和丸中5-羟甲基糠醛的限量检查
- Author:
NIU Chenjin
;
AN Jie
;
QIU Shuowen
;
QU Jia
- Publication Type:Journal Article
- Keywords:
Yueju Baohe pills;
5-hydroxymethylfurfural;
limit test;
HPLC;
statistical analysis;
quality control
- From:
Drug Standards of China
2024;25(1):055-061
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To establish an HPLC method to detect the limit of 5-hydroxymethylfurfural in Yueju Baohe pills.
Methods: A Zafex Acutfex PW-C18 column（4.6 mm×250 mm, 5 μm） was adopted with mobile phase consisted of acetonitrile-0.1% formic acid aqueous solution（2:98）at the flow rate of 1.0 mL·min-1. The column temperature was 40 ℃ and the detective wavelength was set at 284 nm.
Results: The linear range of 5-hydroxymethylfurfural was 0.491 9-122.98 μg·mL-1 (r=1.000). The average recovery(n=6) was 97.99% with RSD 0.61%. All of the RSDs for precision,repeatability and stability met the methodological requirements. According to the proposed limit, 17 of the 65 batches of samples did not meet the requirements, and the failure rate was 26.15%.
Conclusion: The established method is suitable for the limit test of 5-hydroxymethylfurfural in Yueju Baohe pills.There was a significant difference in the content of 65 batches of samples. It is necessary to investigate the limit of 5-hydroxymethylfurfural in Yueju Baohe pills.
- Full text:202408101322148063320240209.pdf
