Stability Indicating HPLC Method Development: A Review

  • 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.

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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

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How to Cite
Saudagar, R. B., & Mahale, M. M. (2019). Stability Indicating HPLC Method Development: A Review. Journal of Drug Delivery and Therapeutics, 9(3-s), 1103-1104. https://doi.org/10.22270/jddt.v9i3-s.2965