Method for pretreating ranitidine hydrochloride sample
AssigneeHunan Institute for Drug Inspection and Testing
InventorsShuai Li, Bin Liao, Hongyu Chen, Yuxin Li, Yanming Liu, Guipeng Tang, Yang Gao
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AssigneeHunan Institute for Drug Inspection and Testing
InventorsShuai Li, Bin Liao, Hongyu Chen, Yuxin Li, Yanming Liu, Guipeng Tang, Yang Gao
Estimating the term…
Disclosed is a method for pretreating Ranitidine hydrochloride sample, comprising steps: S1, weighing the Ranitidine hydrochloride sample containing an impurity of N-nitrosodimethylamine; S2, preparing a test solution of Ranitidine hydrochloride so that the concentration of N-nitrosodimethylamine in the test solution reaches the detection limit of high-performance liquid chromatography; S3, adding an alkaline solution to the Ranitidine hydrochloride test solution, wherein the alkaline solution reacts completely with hydrochloric acid in Ranitidine hydrochloride to give a Ranitidine neutralizing solution; S4, adding a silver ion solution to the Ranitidine neutralizing solution, and silver ions undergo a complete complexation reaction with secondary amino groups in Ranitidine to generate a precipitate. The precipitation of Ranitidine in the high-concentration Ranitidine test article is removed without producing NDMA as a by-product while retaining NDMA in the sample, greatly improving the sensitivity of NDMA detection and meeting the detection requirements of various types of mass spectrometry.
A method for pretreating a sample of Ranitidine hydrochloride, comprising the following steps:
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