UGC Approved Journal no 63975(19)
New UGC Peer-Reviewed Rules

ISSN: 2349-5162 | ESTD Year : 2014
Volume 13 | Issue 2 | February

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Published in:

Volume 11 Issue 3
March-2024
eISSN: 2349-5162

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Published Paper ID:
JETIR2403251


Registration ID:
531018

Page Number

c412-c416

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Title

Development of Stability – Indicating Analytical Procedures by HPLC : A REVIEW

Abstract

The evaluation of the chemical stability studies of small molecule pharmaceuticals rely primarily on the availability of a chromatographic or other separation assay capable of separating and quantifying major impurities and degradation products. A staged approach to the development of stability-indicating HPLC methods, consistent with current regulatory guidelines, is outlined. Practical recommendations are provided for developing forced degradation protocols at every stage of drug development and avoiding common pitfalls that may confuse data interpretation. Consideration is given to special cases such as stereoisomeric drugs, polymorphs, and combination drug products.

Key Words

HPLC, Validation, Stability indicating method, Drug substance.

Cite This Article

"Development of Stability – Indicating Analytical Procedures by HPLC : A REVIEW ", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.11, Issue 3, page no.c412-c416, March-2024, Available :http://www.jetir.org/papers/JETIR2403251.pdf

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2349-5162 | Impact Factor 7.95 Calculate by Google Scholar

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 7.95 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

Cite This Article

"Development of Stability – Indicating Analytical Procedures by HPLC : A REVIEW ", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.11, Issue 3, page no. ppc412-c416, March-2024, Available at : http://www.jetir.org/papers/JETIR2403251.pdf

Publication Details

Published Paper ID: JETIR2403251
Registration ID: 531018
Published In: Volume 11 | Issue 3 | Year March-2024
DOI (Digital Object Identifier):
Page No: c412-c416
Country: Chirala, bapatla district , Andhra Pradesh , India .
Area: Pharmacy
ISSN Number: 2349-5162
Publisher: IJ Publication
Published Paper URL :: https://www.jetir.org/view?paper=JETIR2403251
Published Paper PDF: https://www.jetir.org/papers/JETIR2403251

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