alexa Impurity Determination In Pharmaceuticals By Ion Chromatography�Pulsed Amperometric Detector (IC-PAD) | 15333
ISSN: 2157-7064

Journal of Chromatography & Separation Techniques
Open Access

Like us on:

OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations
700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

International Expo and Conference on Analytrix & HPLC

Xiaohui Yang
ScientificTracks Abstracts: J Chromat Separation Techniq
DOI: 10.4172/2157-7064.S1.002
Abstract
I on Chromatography (IC) is recently gaining popularity for determining impurities in pharmaceuticals. The ionic separation mechanism gives IC a different separation selectivity than reversed-phase HPLC. Pulsed Amperometric Detection (PAD) coupled with anion-exchange chromatography is a powerful technique to determine the compounds that undergo oxidation or reduction at a noble metal surface. The current generated is proportional to the analyte concentration, which can be detected and quantitated. For many drugs or their impurities that lack UV chromophores, PAD provides an alternate simple and sensitive detection method. IC-PAD has been used extensively for direct detection of monosaccharides, oligosaccharides, amino acids, proteins, and glycoproteins.Two case studies of impurity determination by IC-PAD will be discussed in this presentation. The first study is an anion-exchange IC method coupled with PAD proposed by USP for determination of galactosamine in total hexosamine in Heparin drug substance. Galactosamine can be formed from any oversulfated chondroitin sulfate, dermatan sulfate and other galactosamine-containing impurities in Heparin drug substance upon acid hydrolysis. Galactosamine was separated from glucosamine by IC and determined by PAD. The verified galactosamine range in Heparin is 0.4 to 2.1%, with LOQ at 0.29%. The second study is for determination of Beta Cyclodextrin (BetaDex) in Betadex Sulfobutyl Ether Sodium (BSES) raw material by IC-PAD also proposed by USP. BetaDex is the starting material to synthesize the sulfobutyl ether derivatives and the BetaDex limit is 0.1%. Because of poor UV signal, detection of Cyclodextrin (CD) is always a challenge. Evaporative light scattering detection, mass spectrometry, conductivity, and indirect UV detection have been used for detection of CD. However, poor sensitivity or selectivity, long analysis time, and difficulties for operation make these methods unfavorable. In this case study, BetaDex was determined by IC-PAD from 0.05% to 0.15% in BSES raw material. Both of these methods have been successfully evaluated and verified in the R&D laboratory with respect to specificity, accuracy, precision, linearity, range, LOQ and LOD.
Biography

Xiaohui Yang completed her Masters degree in Analytical Chemistry from Southern Illinois University, Carbondale in 1999 and since then she has worked as an Analytical Chemist in pharmaceutical industry for the past 13 years. Her work experience includes drug pharmacokinetic support by LC/MS/MS at Pfizer and Eli Lilly Co., and analytical method development for drug products at Baxter Healthcare Corporation.

image PDF   |   image HTML
 
Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2018-19
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

Agri & Aquaculture Journals

Dr. Krish

[email protected]

+1-702-714-7001Extn: 9040

Biochemistry Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Business & Management Journals

Ronald

[email protected]

1-702-714-7001Extn: 9042

Chemistry Journals

Gabriel Shaw

[email protected]

1-702-714-7001Extn: 9040

Clinical Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Engineering Journals

James Franklin

[email protected]

1-702-714-7001Extn: 9042

Food & Nutrition Journals

Katie Wilson

[email protected]

1-702-714-7001Extn: 9042

General Science

Andrea Jason

[email protected]

1-702-714-7001Extn: 9043

Genetics & Molecular Biology Journals

Anna Melissa

[email protected]

1-702-714-7001Extn: 9006

Immunology & Microbiology Journals

David Gorantl

[email protected]

1-702-714-7001Extn: 9014

Materials Science Journals

Rachle Green

[email protected]

1-702-714-7001Extn: 9039

Nursing & Health Care Journals

Stephanie Skinner

[email protected]

1-702-714-7001Extn: 9039

Medical Journals

Nimmi Anna

[email protected]

1-702-714-7001Extn: 9038

Neuroscience & Psychology Journals

Nathan T

[email protected]

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

Ann Jose

[email protected]

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

[email protected]

1-702-714-7001Extn: 9042

 
© 2008- 2018 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version