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filingDate 2017-12-30-04:00^^<http://www.w3.org/2001/XMLSchema#date>
grantDate 2021-03-30-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationDate 2021-03-30-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber CN-108663441-B
titleOfInvention Method for checking related substances of tacalcitol ointment
abstract The invention discloses a high performance liquid chromatography analysis method for related substances of a low-concentration tacalcitol ointment, which adopts octadecylsilane chemically bonded silica as a filler, adopts a mixed solution of acetonitrile and water as a mobile phase, and particularly adopts a vortex-extraction-concentration mode to obtain a test solution and a reference solution, thereby greatly ensuring that the drugs with extremely low dosage and related substances in the ointment can be detected, and optimizing a solvent system for dissolving and concentrating the drugs to dry residues, so that the peak shape is sharper and the reproducibility is good. The method can simultaneously analyze all known impurities in the tacalcitol ointment, and can effectively control the content of each known impurity by a main component self-contrast method added with a correction factor, the separation degrees between each impurity peak and between the main peak and an adjacent impurity peak are both greater than 1.5, and the peak purities of the main peak and each impurity peak are both greater than 1.0. The invention provides a simple and reliable analysis method for the quality control of tacalcitol ointment.
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