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Volume 76
Issue 4
10.3797/scipharm.0808-08
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Article

Spectral Characterization of Degradation Impurities of Paroxetine Hydrochloride Hemihydrate

by
Nirmala MUNIGELA
1,*,
J. Moses BABU
1,
Anjaneyulu YERRAMILLI
3,
Naveen Kumar KOLLA
2,
Vyas KRISHNAMURTHY
1 and
Vijay Vittal MATHAD
2
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.
Sci. Pharm. 2008, 76(4), 653-662; https://doi.org/10.3797/scipharm.0808-08
Submission received: 10 August 2008 / Accepted: 14 September 2008 / Published: 23 September 2008
Versions Notes

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

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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. https://doi.org/10.3797/scipharm.0808-08

AMA Style

MUNIGELA N, BABU JM, YERRAMILLI A, KOLLA NK, KRISHNAMURTHY V, MATHAD VV. Spectral Characterization of Degradation Impurities of Paroxetine Hydrochloride Hemihydrate. Scientia Pharmaceutica. 2008; 76(4):653-662. https://doi.org/10.3797/scipharm.0808-08

Chicago/Turabian Style

MUNIGELA, Nirmala, J. Moses BABU, Anjaneyulu YERRAMILLI, Naveen Kumar KOLLA, Vyas KRISHNAMURTHY, and Vijay Vittal MATHAD. 2008. "Spectral Characterization of Degradation Impurities of Paroxetine Hydrochloride Hemihydrate" Scientia Pharmaceutica 76, no. 4: 653-662. https://doi.org/10.3797/scipharm.0808-08

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