Quick Menu

Upcoming Journals
  • No Upcoming Journals

British Journal of Pharmaceutical Research

British Journal of Pharmaceutical Research, ISSN: 2231-2919,Vol.: 4, Issue.: 1 (01-15 January)


Original Research Article


Development and Validation of Densitometry TLC Stability Indicating Method for Quantitative Determination of Azelastine Hydrochloride and Emedastine Difumarate in Their Drug Products



Nahla N. Salama1*, Sawsan A. Abdel-Razeq2, Shimaa Abdel-Atty1 and Naglaa El-Kosy1

1Pharmaceutical Chemistry Department, National Organization for Drug Control and Research (NODCAR), Giza, Egypt.
2Analytical Chemistry Department, Faculty of Pharmacy, Al-Azhar University, Cairo, Egypt.




Aims: Stability indicating densitometry-TLC assay was established and validated for determination of azelastine hydrochloride (AZT) and emedastine difumarate (ETD) in the presence of their acid and oxidative degradants.
Methodology: Forced degradation was performed using 30% H2O2 and 5 M HCl. The method was based on thin-layer chromatographic separation of the two drugs from their degradants, using methanol- 10% ammonia (9.5:0.5, v/v) as developing system, followed by densitometric measurements of the intact drug spots at 292 and 283 nm, for azelastine hydrochloride and emedastine difumarate respectively.
Results: The linear range was 0.5 - 10.0 μg/spot, with mean recoveries of 100.09 ± 0.53% and 100.36 ± 0.40% for azelastine hydrochloride and emedastine difumarate respectively.
Conclusion: The proposed method was successfully applied for the routine quality control analysis of both drugs in laboratory prepared mixtures and commercially available preparations. The degradation products were identified by IR and MS and the pathways were illustrated. The method was validated according to ICH.


Keywords :

Azelastine hydrochloride; emedastine difumarate; densitometry-TLC; stability; validation.


Full Article - PDF    Page 79-92    Article Metrics


DOI : 10.9734/BJPR/2014/3693

Review History    Comments

Search this site

Advanced Search

Announcement & News

SCOPUS selected Annual Research & Review in Biology (ARRB)

We are delighted to inform that famous indexing organization SCOPUS (from Elsevier) selected  A...

Index Copernicus Evaluation Result Released

We are delighted to inform that Index Copernicus (a leading indexing organization from Pol...

Journal Repository (JR): Permanent Digital Archiving of SDI journals

SDI is happy to announce that all our journals are now permanently archived in Journal Repository (J...

Index Copernicus Value of British Journal of Medicine and Medical Research

  We are delighted to inform that Index Copernicus (a leading indexing organization ...

SDI journal got 35th ranking in Publons

We are delighted to announce (as of 04/01/2016) that British Journal of Medicine and Medical Re...

Growth of SDI and world publication market

As of 2014, total 25,064 journals are competing in World market of journal publication. In 2011, tot...

Publication and site statistics (up to Sept, 2015)

  Number of submission: 22181 (Total up to Sept, 2015) Number of published paper: 10949&n...

Index Medicus selected 15 SDI journals

We are delighted to inform that Index Medicus (IMSEAR) has selected following 15 SDI journals for in...

SCIENCEDOMAIN international received 5844 submissions in 2013

SCIENCEDOMAIN international is pleased to announce that it has received 5844 submissions in 2013, ac...

Science (IF: 31) report confirmed the high standard of SDI journal

As per a recent report (Link) of Science journal (present Impact factor 31), one of our journal (Bri...


  • No Awards listed.

Browser Compatibility : Mozila firefox, Google Crome and IE 7 & above. Creative Commons License Terms & Condition   |   Privacy Policy   |   Join Us   |   Help   |   Contact Us
© Copyright 2010-2017, SCIENCEDOMAIN international. All rights reserved.