Quality by design: A systematic and rapid liquid chromatography and mass spectrometry method for eprosartan mesylate and its related impurities using a superficially porous particle column-Reference-Cited by-同舟云学术

Quality by design: A systematic and rapid liquid chromatography and mass spectrometry method for eprosartan mesylate and its related impurities using a superficially porous particle column

Published:2014-07-10 Issue:16 Volume:37 Page:2160-2171
ISSN:1615-9306
Container-title:Journal of Separation Science
language:en
Short-container-title:J. Sep. Science

Author:

Kalariya Pradipbhai D.¹,Kumar Talluri Murali V. N.¹,Gaitonde Vinay D.²,Devrukhakar Prashant S.¹,Srinivas Ragampeta¹

Affiliation:

1. Department of Pharmaceutical Analysis; National Institute of Pharmaceutical Education & Research; Balanagar Andhra Pradesh India

2. Biotech India Pvt. Ltd; Mumbai India

Publisher

Wiley

Subject

Filtration and Separation,Analytical Chemistry

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/jssc.201301364/fullpdf

Reference48 articles.

1. International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q8 (R2): Pharmaceutical Development, ICH, Geneva, Switzerland 2009

2. International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q9: Quality Risk Management, ICH, Geneva, Switzerland 2005

3. International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q10: Pharmaceutical Quality System, ICH, Geneva, Switzerland 2008

4. Quality by Design (QbD) Based Development of a Stability Indicating HPLC Method for Drug and Impurities

5. Expanding the term “Design Space” in high performance liquid chromatography (I)

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