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XU Jing, PENG Hong, XIONG Xianzhao. Determination of related substances in (E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid by HPLC[J]. Journal of China Pharmaceutical University, 2020, 51(5): 538-543. DOI: 10.11665/j.issn.1000-5048.20200505
Citation: XU Jing, PENG Hong, XIONG Xianzhao. Determination of related substances in (E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid by HPLC[J]. Journal of China Pharmaceutical University, 2020, 51(5): 538-543. DOI: 10.11665/j.issn.1000-5048.20200505
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Determination of related substances in (E)-4-[2-(4-chlorophenoxy)-2-methylpanoyloxy]-3-methoxyphenyl acrylic acid by HPLC

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  • Received Date: February 19, 2020
  • Revised Date: September 23, 2020
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    • 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.
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    • References (5)
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