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Sci. Pharm. 2008, 76(4), 653-662; doi:10.3797/scipharm.0808-08 (registering DOI)

Spectral Characterization of Degradation Impurities of Paroxetine Hydrochloride Hemihydrate

1
Department of Analytical Research, Discovery Research, Dr. Reddy’s Laboratories, Bollaram Road, Miyapur, Hyderabad 500 049, India
2
Research and development, Dr. Reddy’s Laboratories Ltd., Integrated Product Development, Unit-III, Plot No.116, S.V. Co-Op.Indl. Estate, Bollaram, Jinnaram, Medak-502 325, India
3
Jawaharlal Nehru Technological University, Kukatpally, Hyderabad-500 072, India
*
Author to whom correspondence should be addressed.
Received: 10 August 2008 / Accepted: 14 September 2008 / Published: 23 September 2008
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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.
Keywords: Paroxetine; Degradation; NMR; HPLC; LC-MS Paroxetine; Degradation; NMR; HPLC; LC-MS
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

MUNIGELA, N.; BABU, J.M.; YERRAMILLI, A.; KOLLA, N.K.; KRISHNAMURTHY, V.; MATHAD, V.V. Spectral Characterization of Degradation Impurities of Paroxetine Hydrochloride Hemihydrate. Sci. Pharm. 2008, 76, 653-662.

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