High performance liquid chromatography HPLC is an essential analytical tool for evaluating drug stability. HPLC methods must be able to isolate, detect, and quantify drug related degradation products that may form during storage or production, and identify drug related impurities that may form during synthesis. .. This article describes strategies and challenges for designing HPLC methods to demonstrate drug stability. It will deepen our understanding of drugs and medicinal chemistry and demonstrate advances in stability that reflect an analytical approach. Several important chromatographic parameters were investigated to improve the detection of potentially related degradants. It is necessary to find suitable solvent and mobile phase samples that provide sufficient stability and compatibility with each component and potential impurities and degradants. This method should be carefully considered as it has the ability to distinguish between primary and secondary decomposers. The study of forced destruction of chemicals and new drugs is essential for the development and characterization of these immobilization methods. Practical guidance is provided at each stage of drug development to develop a forced disposal protocol and avoid common issues that might impede data interpretation. Suraj Nagwanshi | Smita Aher | Rishikesh 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-5 , August 2021, URL: https://www.ijtsrd.com/papers/ijtsrd46310.pdf Paper URL: https://www.ijtsrd.com/pharmacy/other/46310/stability-indicating-hplc-method-development--a-review/suraj-nagwanshi
International Journal of Trend in Scientific Research and Development (IJTSRD)
Volume 5 Issue 5, July-August 2021 Available Online: www.ijtsrd.com e-ISSN: 2456 – 6470
@ IJTSRD | Unique Paper ID – IJTSRD46310 | Volume – 5 | Issue – 5 | Jul-Aug 2021
Page 2286
Stability Indicating HPLC Method Development - A Review
Suraj Nagwanshi
1
, Smita Aher
2
, Rishikesh Bachhav
3
1Department of Quality Assurance Techniques, R. G,
Sapkal College of Pharmacy, Anjaneri, Nashik, Maharashtra, India
2Department of Pharmaceutical Chemistry, R. G, Sapkal College of Pharmacy, Anjaneri, Nashik, Maharashtra, India
3Department of Pharmacology, R. G, Sapkal College of Pharmacy, Anjaneri, Nashik, Maharashtra, India
ABSTRACT
High-performance liquid chromatography (HPLC) is an essential
analytical tool for evaluating drug stability. HPLC methods must be
able to isolate, detect, and quantify drug-related degradation products
that may form during storage or production, and identify drug-related
impurities that may form during synthesis. .. This article describes
strategies and challenges for designing HPLC methods to
demonstrate drug stability. It will deepen our understanding of drugs
and medicinal chemistry and demonstrate advances in stability that
reflect an analytical approach. Several important chromatographic
parameters were investigated to improve the detection of potentially
related degradants. It is necessary to find suitable solvent and mobile
phase samples that provide sufficient stability and compatibility with
each component and potential impurities and degradants. This
method should be carefully considered as it has the ability to
distinguish between primary and secondary decomposers. The study
of forced destruction of chemicals and new drugs is essential for the
development and characterization of these immobilization methods.
Practical guidance is provided at each stage of drug development to
develop a forced-disposal protocol and avoid common issues that
might impede data interpretati