Detection method of fatty acid composition and methoxyaniline value in pharmaceutical excipient castor oil
10.19778/j.chp.2025.02.007
- VernacularTitle:药用辅料蓖麻油中脂肪酸组成和甲氧基苯胺值检测方法的研究
- Author:
Lulu WANG
1
;
Rui YANG
;
Xiaofeng WANG
;
Xiaosong SONG
;
Jing ZHAO
;
Luxia ZHENG
;
Lei CHEN
;
Baoming NING
;
Xia ZHAO
;
Hui-min SUN
Author Information
1. 中国食品药品检定研究院,国家药品监督管理局药用辅料质量研究与评价重点实验室,北京 100050
- Publication Type:Journal Article
- Keywords:
pharmaceutical excipient;
castor oil;
fatty acid;
methoxyaniline;
detection method
- From:
Drug Standards of China
2025;26(2):156-161
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a detection method for fatty acid composition and methoxylaniline value in pharmaceutical excipient castor oil.Methods:The detection of fatty acid composition involves pre-test of the sam-ple using the methanol sodium methylation method,followed by direct injection analysis using gas chromatography,and finally calculating the content of each fatty acid composition using the area normalization method with correction factors.The detection of methoxylaniline value is achieved by dissolving and diluting the sample with isooctane:isopropanol(8∶2,volume ratio),reacting with 4-methoxylaniline,measuring the absorbance at a wavelength of 350 nm,and calculating the methoxylaniline value.Results:Under the composition of fatty acids,the 8 kinds of fatty acids have good separation degree.The methyl ricinoleate and methyl stearate have good linear relationship in the range of 0.1-5.0 mg·mL-1.The repeatabilityand intermediate precision(RSD)ofthe determination results of each fatty acid in the sample are all less than 5%.It is also found that only α-type of linolenic acid is present in castor oil,without γ-type.In the determination of methoxyaniline value,the blank solvent does not interfere with the determination of the sample,and the repeatability RSD is 3.6%.Conclusion:The detection method for fatty acid composition and meth-oxylaniline value established in this article is accurate and reliable,and can be used for the detection of fatty acid composition and methoxylaniline value in pharmaceutical excipient castor oil.
