Determination of the Related Substances in Isosorbide Mononitrate by UPLC

LIU Caiyun, LIU Chaohui, ZHANG Minmin, LIU Siguang, ZHANG Guimin

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主办:上海医药工业研究院
   中国药学会
   中国化学制药工业协会
ISSN 1001-8255   CN 31-1243/R   ZYGZEA
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Chinese Journal of Pharmaceuticals ›› 2020, Vol. 51 ›› Issue (06) : 765-770. DOI: 10.16522/j.cnki.cjph.2020.06.015
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Determination of the Related Substances in Isosorbide Mononitrate by UPLC

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Abstract

A UPLC-UVD method for simultaneous determination of seven impurities in isosorbide mononitrate was established in this study. The separation was performed on a BEH C18 chromatographic column at 25 ℃ with the mobile phase consisting of 0.1% phosphoric acid and acetonitrile by gradient elution at the flow rate of 0.7 ml/min. The results showed that isosorbide mononitrate and seven impurities could be completely separated and they were linear in the test ranges. The detection limits were 21.09 - 24.34 ng/ml, the quantitation limits were 63.27 - 73.01 ng/ml, and the recoveries were 99.21% - 105.11%. The method was simple and had good specificity and accuracy, which could be used for determination of the related substances in isosorbide mononitrate and provided a reference for the quality control.

Key words

ultra performance liquid chromatography / isosorbide mononitrate / related substance

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LIU Caiyun, LIU Chaohui, ZHANG Minmin, LIU Siguang, ZHANG Guimin. Determination of the Related Substances in Isosorbide Mononitrate by UPLC. Chinese Journal of Pharmaceuticals. 2020, 51(06): 765-770 https://doi.org/10.16522/j.cnki.cjph.2020.06.015

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