An HPLC method was established for the determination of related substances in ezetimibe (1) tablets. A Hypersil Gold C8 column was used, with the mobile phase of methanol∶0.05% TFA (50∶50), at the detection wavelength of 232 nm. The resolution between 1 and its diastereoisomer [6, (3R,4S)-1-(4-fluorophenyl)-3-[(3R)-3-(4-
fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one] was 1.8. It was linear for 1, the related substance 2, diastereoisomer 6 and the related substance 3 in the ranges of 12—820, 9.6—640, 12—780 and 12—780 ng/ml, respectively. Their relative correction factors were 0.8, 1.0 and 1.2. Their average recoveries were 102.5%, 104.4% and 97.9%, with RSDs of 1.3%, 1.7% and 2.4%, respectively.
LIU Qingliang, ZHAO Pihua, YANG Yan, WANG Wenf.
Determination of the Related Substances in Ezetimibe Tablets by HPLC. Chinese Journal of Pharmaceuticals. 2016, 47(12): 1573 https://doi.org/10.16522/j.cnki.cjph.2016.12.018