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filingDate 2018-06-26-04:00^^<http://www.w3.org/2001/XMLSchema#date>
inventor http://rdf.ncbi.nlm.nih.gov/pubchem/patentinventor/MD5_3e2347cb9a340142f4bee313495c250f
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publicationDate 2020-01-03-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber CN-110646550-A
titleOfInvention A kind of detection method of related substances in atorvastatin calcium
abstract The invention relates to a method for detecting a related substance in atorvastatin calcium, wherein the related substance is atorvastatin calcium acetonide tert-butyl ester (impurity I), and the method comprises the steps of using high performance liquid chromatography to detect, The chromatographic column used in the liquid chromatography is a reverse chromatographic column, and gradient elution is performed with mobile phase A and mobile phase B, and the mobile phase A is solution A and buffer with a volume ratio of 35-45:55-65. A mixed solution of solutions, the solution A is an acetonitrile-tetrahydrofuran solution with a volume ratio of 800~950:50~200, and the mobile phase B is a solution A with a volume ratio of 40~80:10~30:10~50 A mixed solution of buffer solution-methanol, the detection method can fully separate the various components of atorvastatin calcium related substances, and at the same time, the atorvastatin calcium and tert-butyl acetonide, which cannot be detected in the reference method, can also be accurately and effectively The detection of atorvastatin calcium can effectively improve the drug quality and safety of atorvastatin calcium.
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priorityDate 2018-06-26-04:00^^<http://www.w3.org/2001/XMLSchema#date>
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