Characterization and Analytical Method Validation for Potential Impurities of a Merchantability Drug Substance Fluoxetine HCl
2025
New Method for Testing Impurities in Fluoxetine
publication
Evidence: high
Author Information
Author(s): Reddy Rajani Reddy Janna, Kolli Sunder Kumar, Salakolusu Suresh, Kallam Sudha Divya Madhuri, Raghupathi Jayaprakash Kanijam, Katari Naresh Kumar
Hypothesis
Can a new HPLC method effectively quantify potential impurities in fluoxetine hydrochloride?
Conclusion
The developed HPLC method is simple, precise, and accurate for quantifying impurities in fluoxetine hydrochloride.
Supporting Evidence
- The method was validated to fulfill ICH Q2(R2) requirements.
- The calibration curve was linear over the concentration range from LOQ to 120%.
- The accuracy of the method is within the acceptable limit of 80%–120%.
- The method can be employed for the regular analysis of potential impurities in fluoxetine hydrochloride.
Takeaway
Researchers created a new way to check for bad stuff in a medicine called fluoxetine, making sure it's safe to use.
Methodology
A high-performance liquid chromatography (HPLC) method was developed and validated according to ICH guidelines.
Digital Object Identifier (DOI)
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