alexa Comparative Study of Forced Degradation Behavior of Tel
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)

Research Article

Comparative Study of Forced Degradation Behavior of Telmisartan by UPLC and HPLC and Development of Validated Stability Indicating Assay Method According to ICH Guidelines

Kapendra Sahu, Shikha Sahu, Mohammad Shaharyar and Anees A. Siddiqui*

Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Jamia Hamdard (Hamdard University), Hamdard Nagar, New Delhi-110062, India

*Corresponding Author:
Anees A. Siddiqui
Department of Pharmaceutical Chemistry
Faculty of Pharmacy, Jamia Hamdard (Hamdard University)
Hamdard Nagar, New Delhi-110062, India
Tel: +91-11-26059688/5650
Fax: +91-11-27048685
E-mail: [email protected]

Received date: June 19, 2012; Accepted date: July 07, 2012; Published date: July 13, 2012

Citation: Sahu K, Sahu S, Shaharyar M, Siddiqui AA (2012) Comparative Study of Forced Degradation Behavior of Telmisartan by UPLC and HPLC and Development of Validated Stability Indicating Assay Method According to ICH Guidelines. J Chromat Separation Techniq 3:129. doi:10.4172/2157-7064.1000129

Copyright: © 2012 Sahu K, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

A novel comparative force degradation ultra-performance liquid chromatographic assay method was developed and validated for Telmisartan and its degradation products. Telmisartan was subjected to acid (0.1M HCl), neutral (water) and alkaline (0.1M NaOH) hydrolytic conditions at 80°C, as well as to oxidative decomposition (H2O2) at room temperature. Photolytic studies were carried out by exposing this drug into sunlight (60,000-70,000 lux) for 2 days. Additionally, the solid drug was subjected to 50°C for 60 days in a hot air oven for thermal degradation. The UPLC chromatographic separation was performed on Acquity UPLC BEH C18 column (1.7 μm, 2.1mm×150mm) using isocratic mode (ACN:water, 70:30v/v) at flow rate of 0.2 ml min-1 and HPLC chromatographic separation was achieved on phenomenex C18 using isocratic mode (ACN:10mM ammonium acetate, Ph 4.5, 85:15v/v) at flow rate of 1.0 ml min-1. Telmisartan was found to degrade significantly in acid, base and oxidation, the drug was found to be stable in neutral, thermal and photolytic stress conditions. The ultra performance liquid chromatography (UPLC) and high performance liquid chromatography (HPLC) area %RSD were calculated to be 0.0039 and 0.0015 respectively. The UPLC and HPLC linearity of the proposed method were investigated in the range of 10-50 μg mL-1 and 30-150 μg mL-1 . The r2 value of UPLC and HPLC were found to be 0.9987 and 0.9989 respectively. Method detection limit (MDL) and Method quantification limit (MQL) were found to be 0.250 μg mL-1 and 1.20 μg mL-1 for UPLC and 0.600 μg/ml and 1.900 μg mL-1 respectively for HPLC. The %R.S.D. values for intra-day and inter-day precision were <1.0%, confirming that the method was sufficiently precise. The validation studies were carried out fulfilling ICH requirements. The developed method was simple, fast, accurate and precise and hence could be applied for routine quality control analysis of Telmisartan in solid dosage forms.

Keywords

Share This Page

Additional Info

Loading
Loading Please wait..
 
Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

Agri, Food, Aqua and Veterinary Science Journals

Dr. Krish

[email protected]

1-702-714-7001 Extn: 9040

Clinical and Biochemistry Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Business & Management Journals

Ronald

[email protected]

1-702-714-7001Extn: 9042

Chemical Engineering and Chemistry Journals

Gabriel Shaw

[email protected]

1-702-714-7001 Extn: 9040

Earth & Environmental Sciences

Katie Wilson

[email protected]

1-702-714-7001Extn: 9042

Engineering Journals

James Franklin

[email protected]

1-702-714-7001Extn: 9042

General Science and Health care Journals

Andrea Jason

[email protected]

1-702-714-7001Extn: 9043

Genetics and Molecular Biology Journals

Anna Melissa

[email protected]

1-702-714-7001 Extn: 9006

Immunology & Microbiology Journals

David Gorantl

[email protected]

1-702-714-7001Extn: 9014

Informatics Journals

Stephanie Skinner

[email protected]

1-702-714-7001Extn: 9039

Material Sciences Journals

Rachle Green

[email protected]

1-702-714-7001Extn: 9039

Mathematics and Physics Journals

Jim Willison

[email protected]

1-702-714-7001 Extn: 9042

Medical Journals

Nimmi Anna

[email protected]

1-702-714-7001 Extn: 9038

Neuroscience & Psychology Journals

Nathan T

[email protected]

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

John Behannon

[email protected]

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

[email protected]

1-702-714-7001 Extn: 9042

 
© 2008-2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version
adwords