Abstract
Two unknown impurities were detected in stressed samples (by hydrochloric acid and hydrogen peroxide) of paroxetine hydrochloride hemihydrate (an active pharmaceutical ingredient – API) using a gradient reversed-phase high performance liquid chromatography (HPLC). These impurities were enriched and were present up to 30% in the degraded sample. The impurities were isolated from the degraded sample by column purification. Spectral data of the isolated impurities were collected. Based on the spectral data of two dimensional nuclear magnetic spectroscopy (2D-NMR) and mass spectrometry (MS) Impurity-1 and Impurity-2 were characterized as (3S,4R)-3-{[(6-chloro-1,3-benzodioxol-5-yl)oxy]methyl}-4-(4-fluorophenyl)piperidine and [(3S,4R)-4-(4-fluorophenyl)piperidin-3-yl]methanol respectively.
Highlights
Paroxetine belongs to the class of antidepressants, as it is a selective serotonin reuptake inhibitor (SSRI) [1]
The impurities were generated during the stability testing of the Active Pharmaceutical Ingredient (API) in acid and peroxide [4]
The analytical high performance liquid chromatography (HPLC) chromatograms of API, impurity-1 and impurity-2 after isolation are shown in Fig. 1 and their structures are shown in Table.1 respectively
Summary
Paroxetine belongs to the class of antidepressants, as it is a selective serotonin reuptake inhibitor (SSRI) [1]. The impurities were enriched by degradation of paroxetine hydrochloride hemihydrate, and subjected to column purification; identified using LC-MS [5] and NMR. Degradation of paroxetine hydrochloride hemihydrate ( referred to as API) under acidic condition and with hydrogen peroxide was found to give two unknown impurities: impurity-1 and impurity-2, respectively whereas using a base and heat stress for 48 hrs did not give rise to unknown impurities.
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