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Development of a Stability-Indicating Analytical Method for Determination of Venetoclax Using AQbD Principles
Nina Žigart1,2, Zdenko Časar1,2
1Sandoz Development Center Slovenia, Analytics Department, Lek Pharmaceuticals d.d., SI-1526 Ljubljana, Slovenia.
Abstract:
Venetoclax is an emerging drug for the treatment of various types of blood cancers. It was first approved in 2016 for the treatment of relapsed and refractory chronic lymphocytic leukemia. Later, the indications expanded, and multiple research as well as clinical studies are still conducted involving venetoclax. No analytical method for the determination of venetoclax can currently be found in the literature. We developed a mass spectrometry-compatible stability-indicating ultrahigh-performance liquid chromatography (LC) method for venetoclax. The LC method was developed using analytical quality by design principles. The developed method is able to separate venetoclax and its degradation products. The method was validated in the working point where a linearity range was established and accuracy, repeatability, and selectivity were assessed. Venetoclax is the only Bcl-2 protein inhibitor on the market. It is very effective in combinational therapy, so future drug development involving venetoclax may be expected. A stability-indicating method could aid in the development of new pharmaceutical products with venetoclax.
Insights
A new stability-indicating ultrahigh-performance liquid chromatography (LC) method was developed for venetoclax, a crucial drug for blood cancers. This validated analytical method can separate venetoclax from its degradation products, aiding future drug development.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Sciences
- Oncology
Background:
- Venetoclax is a significant therapeutic agent for various blood cancers, including chronic lymphocytic leukemia.
- Existing literature lacks a validated analytical method for venetoclax determination and stability assessment.
- Venetoclax functions as a selective B-cell lymphoma 2 (Bcl-2) protein inhibitor.
Purpose of the Study:
- To develop and validate a mass spectrometry-compatible, stability-indicating ultrahigh-performance liquid chromatography (LC) method for venetoclax.
- To establish an analytical method capable of separating venetoclax from its potential degradation products.
Main Methods:
- Utilized analytical quality by design (QbD) principles for method development.
- Developed an ultrahigh-performance liquid chromatography (UHPLC) method compatible with mass spectrometry.
- Validated the method for linearity, accuracy, repeatability, and selectivity.
Main Results:
- Successfully developed a stability-indicating LC method for venetoclax.
- The method effectively separates venetoclax from its degradation products.
- Method validation confirmed linearity, accuracy, repeatability, and selectivity.
Conclusions:
- A robust and validated stability-indicating LC method for venetoclax has been established.
- This analytical method is crucial for supporting ongoing and future research and development of venetoclax-based therapies.
- The method will facilitate the development of new pharmaceutical products containing venetoclax.
