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.
Highlights
The stability of pharmaceutical product requires more attention because the stability get directly affects the safety, purity and efficacy of drug products
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
Search area This review summarizes the current regulatory requirements for the practical performance of forced degradation and its application for the development of stability indicating method
Summary
The stability of pharmaceutical product requires more attention because the stability get directly affects the safety, purity and efficacy of drug products. The International Council for Harmonization (ICH) and Food and Drug Administration (FDA) provided the different guidelines and requirements for stability testing data [2]. According to different guidelines generally two types of stability testing studies, like, long-term stability studies and accelerated stability studies. In case of long-term studies, the require time for completion of study is about 12 months. Long-term stability studies useful for identification and separation of degraded products. In case of accelerated stability testing required around 6 months, Intermediate stability testing is proceeding for 6 months at conditions milder than accelerated studies [3]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
