Objective: To establish an HPLC method for the determination of the related substances B(4-chloro-5-sulfamylanthranilic acid),single maximum impurity and total impurities in furosemide tablets. Methods: HPLC and principal component self- control with correction factor were adopted. The determination was performed on an Agilent ZORBAX C18 column (250 mm×4.6 mm, 5 μm). The mobile phase consisted of water-tetrahydrofuran-glacial acetic acid tetrabutyl (70:30:1).The flow rate was 1.0 mL·min-1, the detection wavelength was set at 272 nm, the injection volume was 20 μL, and the column temperature was maintained at 30 ℃. The linear equations of furosemide and impurity B were drawn. The correction factors of impurity B related to furosemide were calculated by slope,and relative retention time was used to determine the position of impurity B. The contents of impurity B,single maximum impurity and total impurities in 15 batches of Furosemide tablets produced by 6 pharmaceutical companies were determined and compared with the results of impurity control method. Results: The relative retention time of impurity B was 0.31 and the linear range of impurity B was 0.041-12.19 μg·mL-1. The correction factor was 1.06. The detection limit was 0.40 ng,and the limit of quantification was 0.81 ng.Comparing the results measured byprincipal component self-control with correct factor methodand the external standard method, the variationwas ±0.01%, indicating that there was no significant difference between the two methods. Conclusion: The method is proved to be simple,rapid and accurate for the content determination of related substances in furosemide tablets.
HU Ze-kai, LUO Yuan
. Determination of related substances in furosemide tablets by HPLC-principal component self-control with correct factor*[J]. Chinese Journal of Pharmaceutical Analysis, 2022
, 42(8)
: 1433
-1439
.
DOI: 10.16155/j.0254-1793.2022.08.17
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