Development and validation of a rapid chromatographic method for the analysis of flunarizine and its main production impurities

Niamh O'Connor; Michael Geary; Mary Wharton; Paul Sweetman

doi:10.1016/j.jpha.2012.12.005

Development and validation of a rapid chromatographic method for the analysis of flunarizine and its main production impurities

Niamh O'Connor, Michael Geary, Mary Wharton, Paul Sweetman

Department of Applied Science

Research output: Contribution to journal › Article › peer-review

3 Citations (Scopus)

Abstract

A rapid selective method for the analysis of flunarizine and its associated impurities was developed and validated according to ICH guidelines. The separation was carried out using a Thermo Scientific Hypersil Gold C18 column (50 mm×4.6 mm i.d., 1.9 μm particle size) with a gradient mobile phase of acetonitrile-ammonium acetate-tetrabutylammoniumhydrogen sulfate buffer, at a flow rate of 1.8 mL/min and UV detection at 230 nm. Naturally aged samples were also tested to determine sample stability. A profile of sample and impurity breakdown was also presented.

Original language	English
Pages (from-to)	211-214
Number of pages	4
Journal	Journal of Pharmaceutical Analysis
Volume	3
Issue number	3
DOIs	https://doi.org/10.1016/j.jpha.2012.12.005
Publication status	Published - Jun 2013

Keywords

Active pharmaceutical ingredient
Flunarizine
HPLC
Sub 2 μm column

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10.1016/j.jpha.2012.12.005

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abstract = "A rapid selective method for the analysis of flunarizine and its associated impurities was developed and validated according to ICH guidelines. The separation was carried out using a Thermo Scientific Hypersil Gold C18 column (50 mm×4.6 mm i.d., 1.9 μm particle size) with a gradient mobile phase of acetonitrile-ammonium acetate-tetrabutylammoniumhydrogen sulfate buffer, at a flow rate of 1.8 mL/min and UV detection at 230 nm. Naturally aged samples were also tested to determine sample stability. A profile of sample and impurity breakdown was also presented.",

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author = "Niamh O'Connor and Michael Geary and Mary Wharton and Paul Sweetman",

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AU - O'Connor, Niamh

AU - Geary, Michael

AU - Wharton, Mary

AU - Sweetman, Paul

PY - 2013/6

Y1 - 2013/6

N2 - A rapid selective method for the analysis of flunarizine and its associated impurities was developed and validated according to ICH guidelines. The separation was carried out using a Thermo Scientific Hypersil Gold C18 column (50 mm×4.6 mm i.d., 1.9 μm particle size) with a gradient mobile phase of acetonitrile-ammonium acetate-tetrabutylammoniumhydrogen sulfate buffer, at a flow rate of 1.8 mL/min and UV detection at 230 nm. Naturally aged samples were also tested to determine sample stability. A profile of sample and impurity breakdown was also presented.

AB - A rapid selective method for the analysis of flunarizine and its associated impurities was developed and validated according to ICH guidelines. The separation was carried out using a Thermo Scientific Hypersil Gold C18 column (50 mm×4.6 mm i.d., 1.9 μm particle size) with a gradient mobile phase of acetonitrile-ammonium acetate-tetrabutylammoniumhydrogen sulfate buffer, at a flow rate of 1.8 mL/min and UV detection at 230 nm. Naturally aged samples were also tested to determine sample stability. A profile of sample and impurity breakdown was also presented.

KW - Active pharmaceutical ingredient

KW - Flunarizine

KW - HPLC

KW - Sub 2 μm column

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DO - 10.1016/j.jpha.2012.12.005

M3 - Article

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SN - 2095-1779

VL - 3

SP - 211

EP - 214

JO - Journal of Pharmaceutical Analysis

JF - Journal of Pharmaceutical Analysis

IS - 3

ER -

Development and validation of a rapid chromatographic method for the analysis of flunarizine and its main production impurities

Abstract

Keywords

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