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Acta Pharm. 2013 Sep;63(3):385-96. doi: 10.2478/acph-2013-0025.

Synthesis of the impurities during the manufacture of bulk drug midazolam and separation of these impurities by HPLC.

Abstract

During the manufacture of bulk drug midazolam various impurities arised that can be the related products or degradation products. Structures of eight impurities that can arise during the manufacture of bulk drug midazolam were proposed. In the present work, synthesis of these impurities and their characterization by different spectroscopic techniques have been done. HPLC method was developed for the separation of impurities from the bulk drug. The developed method separates midazolam from its eight impurities/degradation products within a run time of 45 min.

PMID:
24152898
DOI:
10.2478/acph-2013-0025
[Indexed for MEDLINE]
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