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HU Zhongfang, SONG Min, HANG Taijun. Studies on related substances in cinacalcet hydrochloride by LC-MS[J]. Journal of China Pharmaceutical University, 2016, 47(6): 719-726. DOI: 10.11665/j.issn.1000-5048.20160615
Citation: HU Zhongfang, SONG Min, HANG Taijun. Studies on related substances in cinacalcet hydrochloride by LC-MS[J]. Journal of China Pharmaceutical University, 2016, 47(6): 719-726. DOI: 10.11665/j.issn.1000-5048.20160615
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Studies on related substances in cinacalcet hydrochloride by LC-MS

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    • Abstract
  • To develop an LC-MS method for the separation and identification of the related substances in cinacalcet hydrochloride. The separation was carried out on a Thermo BDS Hypersil C18 column(100 mm×4. 6 mm, 2. 4 μm)with mobile phase consisting of 0. 1% ammonium acetate buffer-acetonitrile(93∶7)(A)and acetonitrile(B)by gradient elution. The related substances were identified by electrospray positive ionization high resolution TOF/MS and MS/MS, and verified further through reference substances. Cinacalcet hydrochloride and itsrelated substances were separated under the established LC-MS condition. Ten related substances were detected and identified to be one starting material, one intermediate, four synthetic by-products and five degradation products. It showed that the LC-MS method was useful for separating and identifying the related substances in cinacalcet hydrochloride. And the results obtained are valuable for cinacalcet hydrochloride manufacturing process control and quality assurance.
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    • References (14)
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