Futuristic review on progress in force degradation studies and stability indicating assay method for some antiviral drugs

Jaya P.  Ambhore; Vaibhav S.  Adhao; Rameshwar S.  Cheke; Ritesh R.  Popat; Shital J.  Gandhi

doi:10.30574/gscbps.2021.16.1.0172

Authors

Jaya P. Ambhore Department of Pharmaceutical Chemistry, Dr. Rajendra Gode College of Pharmacy, Malkapur, Maharashtra, India.
Vaibhav S. Adhao Department of Pharmaceutical Chemistry, Dr. Rajendra Gode College of Pharmacy, Malkapur, Maharashtra, India.
Rameshwar S. Cheke Department of Pharmaceutical Chemistry, Dr. Rajendra Gode College of Pharmacy, Malkapur, Maharashtra, India.
Ritesh R. Popat Department of Pharmaceutics, Dr. Rajendra Gode College of Pharmacy, Malkapur, Maharashtra, India.
Shital J. Gandhi Department of Pharmaceutics, Dr. Rajendra Gode College of Pharmacy, Malkapur, Maharashtra, India.

DOI:

https://doi.org/10.30574/gscbps.2021.16.1.0172

Keywords:

Intrinsic stability, Degradants, Forced degradation, Stability indicating methods

Abstract

Force degradation studies of drug substance give perceptive knowledge about the intrinsic stability of the molecule as well as possible degradants which formed during the shelf life of drug and thus, aid within the successive development of its stable formulation. A number of analytical methods with hyphenated techniques are required for the identification, determination and characterization of degraded product and impurities produce during different conditions of stress studies; Chromatographic methodology play a vital role in the field of impurity and degradation profiling .This review summarizes the current regulatory requirements guidelines for the laboratory performance of forced degradation and its application for the development of stability indicating method. There are number of strategies have been implemented for the quantitative assessment of antiviral drugs. This study will provide detailed literature on stability- indicating HPLC/ RP-HPLC approaches for the development and validation of various antiviral drugs.

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