Stability Indicating HPLC Method Development: A Review

Authors

  • R B Saudagar Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjaneri - 422213, Nasik, Maharashtra, India
  • Manisha M Mahale Department of Quality Assurance Technique, R.G. Sapkal College of Pharmacy, Anjaneri - 422213, Nasik, Maharashtra, India

Abstract

High performance liquid chromatography is one of the most accurate method widely used for quantitative as well as qualitative analysis of drug product and it is used for determining drug product stability. Stability indicating HPLC methods are used to separate various drug related impurities that are formed during the synthesis or manufacturing of drug product. This article discusses the strategies and issues regarding the development of stability indicating HPLC system for drug substance.

Keywords: stability indicating method, high performance liquid chromatography, drug substance.

DOI

https://doi.org/10.22270/jddt.v9i3-s.2965

Author Biographies

R B Saudagar, Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjaneri - 422213, Nasik, Maharashtra, India

Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy,      Anjaneri - 422213, Nasik, Maharashtra, India

Manisha M Mahale, Department of Quality Assurance Technique, R.G. Sapkal College of Pharmacy, Anjaneri - 422213, Nasik, Maharashtra, India

Department of Quality Assurance Technique, R.G. Sapkal College of Pharmacy, Anjaneri - 422213, Nasik, Maharashtra, India

Published

22-06-2019
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How to Cite

1.
Saudagar RB, Mahale MM. Stability Indicating HPLC Method Development: A Review. J. Drug Delivery Ther. [Internet]. 2019 Jun. 22 [cited 2025 Apr. 26];9(3-s):1103-4. Available from: https://www.jddtonline.info/index.php/jddt/article/view/2965

Issue

Vol. 9 No. 3-s (2019): Volume 9, Issue 3-s, May-June 2019 (Supplement Issue)

Section

Review

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How to Cite

1.
Saudagar RB, Mahale MM. Stability Indicating HPLC Method Development: A Review. J. Drug Delivery Ther. [Internet]. 2019 Jun. 22 [cited 2025 Apr. 26];9(3-s):1103-4. Available from: https://www.jddtonline.info/index.php/jddt/article/view/2965
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