Investigation on the HPLC method of benzyl benzoate related substances in pharmaceutical excipients
10.19778/j.chp.2024.03.014
- VernacularTitle:药用辅料苯甲酸苄酯有关物质HPLC检测方法的建立
- Author:
Kai DU
1
;
Xiaoyue ZHU
;
Lin WANG
;
Zhe ZHANG
;
Qin HU
Author Information
1. 北京市药品检验研究院,国家药品监督管理局仿制药研究与评价重点实验室,中药成分分析与生物评价北京市重点实验室,北京 102206
- Keywords:
benzyl benzoate;
quality standard;
related substances;
HPLC;
revision suggestions
- From:
Drug Standards of China
2024;25(3):299-302
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish an HPLC method for benzyl benzoate related substances and propose revision suggestions for the quality standard of this excipient.Methods:Phenylsilane bond and silica gel were used as fill-ers,and methanol-1％acetic acid(60:40)was used as the mobile phase at the flow rate of 1.0 mL·min-1.The detection wavelength was 254 nm and the injection amount was 20 μL.Results:Based on the results of the de-struction test and taking into account the separation requirements,the chromatographic conditions for benzyl benzo-ate related substances were confirmed and methodological validation was conducted.The detection limits for benzoic acid and benzaldehyde in related substances were 0.2 μg·mL-1 and 0.01 μg·mL-1.The correction factors for benzoic acid and benzaldehyde were 1.0 and 0.1,respectively.According to the newly established method,six batches of benzyl benzoate samples from four enterprises were inspected for related substances,and benzaldehyde was detected with content from 0.02％to 0.1％.The total amount of impurities was from 0.02％to 0.9％.Conclusion:The newly established method can be added to the quality standards of benzyl benzoate,and different impurity limits can be formulated according to the different administration routes in order to better control drug quality.
