Abstract
Publisher Summary The chapter presents the comprehensive profile for sertraline (L)-lactate. The chapter discusses the nomenclature, formulae, elemental analysis, and appearance of sertraline (L)-lactate. Sertraline is a selective serotonin reuptake inhibitor (SSRI) used to treat depression, obsessive-compulsive disorder, panic disorder, and posttraumatic stress disorder. Sertraline (L)-lactate can be prepared from sertraline hydrochloride, sertraline mandelate, or sertraline free base. The chapter describes the physical properties of sertraline (L)-lactate. The equilibrium solubility of sertraline (L)-lactate in water and other solvents was determined by preparing saturated solutions. These solutions were subsequently filtered, diluted, and assayed by reversed phase high-performance liquid chromatography (HPLC). The particle morphology of sertraline (L)-lactate was studied using optical microscopy and scanning electron microscopy. Sertraline (L)-lactate was characterized by electron impact (EI) and fast atom bombardment (FAB) mass spectrometry. The identity of a sample of sertraline (L)-lactate is established through the use of infrared spectroscopy, reversed-phase HPLC, and thin-layer chromatography (TLC). Potentiometric titration is used to assay samples of sertraline (L)-lactate. Reversed-phase HPLC with UV detection at 210 nm is used to determine the amount of lactic acid in a sample of the drug substance. Thin-layer chromatography is used to establish the identity of sertraline (L)-lactate, and to estimate the levels of potential process-related impurities and degradation products in the drug substance. Degradation studies were performed on sertraline (L)-lactate under strongly acidic, strongly alkaline, and oxidative conditions to identify the potential degradation products of the drug substance.
Published Version
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