SYNTHESIS, CHARACTERIZATION, IDENTIFICATION AND QUANTIFICATION OF SERTRALINE HYDROCHLORIDE RELATED IMPURITIES
Dr. Ajit Anerao*, Dr. Vihar Telange, Nitin Bondre, Satish John, Vikram Dighe, Rajendra Jagushte, Dr. Nitin Pradhan
Sertraline hydrochloride is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class, is synthesized for commercial use as a drug substance in highly pure form. During the synthetic process development studies of Sertraline hydrochloride, an impurity was detected in the final product at levels ranging from 0.05% to 0.15% in gas chromatography (GC) method and its molecular weight was determined by LC–MS analysis. The impurity was identified as 4-(4-chlorophenyl)-3,4-dihydronaphthalen-1(2H)-ol impurity, synthesized and characterized, the process of its formation was discussed in detail. After qualification of impurity standard, it was used as a reference standard for development of quantification by high performance liquid chromatography (HPLC) method.
Keywords: Sertraline hydrochloride, method development, isolation, characterization, LC-MS, NMR, HPLC.
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