High performance liquid chromatography is most powerful tools in analytical chemistry which assessing drug product stability. It is most accurate method for determining the qualitative and quantitative analysis of drug product. Forced degradation plays an important role in development of stability indicating analytical methodology. Stability indicating HPLC methods are used to separate various drug related impurities that are formed during the synthesis or manufacture of drug product. This article discusses the strategies and issues regarding the development of stability indicating HPLC system for drug substance. Forced degradation studies establish degradation pathways of drug substances and drug products. Forced degradation elucidate the possible degradation pathway of the drug substance or the active pharmaceutical ingredient in the drug product. At every stage of drug development practical recommendations are provided which will help to avoid failure. Rushikesh S Mulay | Rishikesh S Bachhav "Stability Indicating HPLC Method Development - A Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-6 , October 2021, URL: https://www.ijtsrd.com/papers/ijtsrd46342.pdf Paper URL : https://www.ijtsrd.com/pharmacy/analytical-chemistry/46342/stability-indicating-hplc-method-development--a-review/rushikesh-s-mulay
International Journal of Trend in Scientific Research and Development (IJTSRD)
Volume 5 Issue 6, September-October 2021 Available Online: www.ijtsrd.com e-ISSN: 2456 – 6470
@ IJTSRD | Unique Paper ID – IJTSRD46342 | Volume – 5 | Issue – 6 | Sep-Oct 2021
Page 250
Stability Indicating HPLC Method Development - A Review
Rushikesh S Mulay
1
, Rishikesh S Bachhav
2
1Department of Quality Assurance, R.G Sapkal College of Pharmacy, Anjeneri Nashik, Maharashtra, India
2Department of Pharmacology, R.G Sapkal College of Pharmacy, Anjeneri Nashik, Maharashtra, India
ABSTRACT
High performance liquid chromatography is most powerful tools in
analytical chemistry which assessing drug product stability. It is most
accurate method for determining the qualitative and quantitative
analysis of drug product. Forced degradation plays an important role
in development of stability indicating analytical methodology.
Stability indicating HPLC methods are used to separate various drug
related impurities that are formed during the synthesis or manufacture
of drug product. This article discusses the strategies and issues
regarding the development of stability indicating HPLC system for
drug substance. Forced degradation studies establish degradation
pathways of drug substances and drug products. Forced degradation
elucidate the possible degradation pathway of the drug substance or
the active pharmaceutical ingredient in the drug product. At every
stage of drug development practical recommendations are provided
which will help to avoid failure.
KEYWORDS: HPLC, forced degradation, Stability indicating study
How to cite this paper: Rushikesh S
Mulay | Rishikesh S Bachhav "Stability
Indicating HPLC Method Development -
A Review" Published in International
Journal of Trend in
Scientific Research
and Development
(ijtsrd),
ISSN:
2456-6470,
Volume-5 | Issue-6,
October
2021,
pp.250-259, URL:
www.ijtsrd.com/papers/ijtsrd46342.pdf
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