Determination of related substances in (E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid by HPLC
10.11665/j.issn.1000-5048.20200505
- VernacularTitle:HPLC法测定(E)-4-[2-(4-氯苯氧基)-2-甲基丙酰氧基]-3-甲氧基苯基丙烯酸的有关物质
- Author:
Jing XU
1
;
Hong PENG
;
Xianzhao XIONG
Author Information
1. 江西中医药大学
- Publication Type:Journal Article
- Keywords:
(E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid;
HPLC;
related substances;
impurity
- From:
Journal of China Pharmaceutical University
2020;51(5):538-543
- CountryChina
- Language:Chinese
-
Abstract:
HPLC method was used for the determination of related substances in (E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid. The separation was achieved by Ultimate XB-C18 column (4.6 mm×150 mm,5 μm) with mobile phase composed of methanol-1% acetic acid water (70∶30) at a wavelength of 275 nm. The results showed that (E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid with various intermediates and compulsory destruction of degradation products were well separated. The impurity limit in three batches of API was less than 0.1% and the main impurity C was isolated and identified. Within the range from 0.20 to 59.96 μg/mL, the mass concentration of impurity C has good linear relationship with the peak area (r=0.999 9). The control method of related substances for (E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid was established by impurity reference method and self-high and low concentration comparison. Methodological validation can be used for the detection of related substances of (E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid.
