지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
커뮤니티
연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
초록· 키워드
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This study introduces a novel analytical method for the assessment of pralsetinib impurities and degradation products (DPs), addressing critical gaps in existing methodologies. This research aims to develop a robust HPLC method for impurity analysis, characterize degradation products using LC-MS, and evaluate the environmental impact of the method. The study began by optimizing HPLC conditions with various columns and buffers, ultimately achieving successful separation using an XBridge<SUP>®</SUP> RP-C18 column with ethanol as solvent A and 50 mM formic acid at pH 2.9. This setup provided excellent peak resolution and symmetry, essential for reliable stability studies. The developed HPLC method was then adapted for HPLC-MS/MS, enhancing sensitivity and detection efficiency of DPs. Stress degradation studies of pralsetinib under different conditions (acidic, basic, oxidative, thermal, and photolytic) revealed significant degradation under acidic (29.3 %) and basic (21.5 %) conditions, with several DPs identified. Oxidative stress resulted in 19.8 % degradation, while thermal and photolytic conditions caused minimal degradation. HPLC-MS/MS analysis identified structures of five degradation products, providing detailed insights into pralsetinib"s stability and degradation pathways. Method validation followed ICH guidelines Q2(R1), confirming method"s specificity, selectivity, sensitivity, linearity, accuracy, precision, and robustness. The method exhibited strong linearity with a coefficient of determination (r²) greater than 0.999 for pralsetinib and its impurities. This method advances impurity detection and DPs characterization, ensuring the quality and safety of pralsetinib. Additionally, method"s environmental impact was assessed, aligning with sustainable analytical practices. These findings provide essential data on pralsetinib"s stability, guiding storage conditions and ensuring its efficacy and safety in pharmaceutical applications.
목차
Abstract
1. Introduction
2. Experimental
3. Results and Discussion
4. Conclusions
References
참고문헌 (21)
참고문헌 신청
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R. V. Bhupatiraju, B. S. Kumar, P. Peddi, and V. S. Tangeti, J. Chem. Metrol., 17(2), 181-198 (2023). http://doi.org/10.25135/jcm.98.2311.2975
A. Y. Li, M. G. McCusker, A. Russo, K. A. Scilla, and A. Gittens, Cancer. Treat. Rev., 81, 101911 (2019). https://doi.org/10.1016/j.ctrv.2019.101911
V. Subbiah, D. Yang, V. Velcheti, A. Drilon, and F. Meric-Bernstam, J. Clin. Oncol., 38(11), 1209-1221 (2020). https://doi.org/10.1200/jco.19.02551
T. E. Stinchcombe, Ther. Adv. Med. Oncol., 12, 1-11 (2020). https://doi.org/10.1177/1758835920928634
R. V. Bhupatiraju, B. S. Kumar, P. Peddi, and V. S. Tangeti, J. Chem. Metrol., 17(2), 181-198 (2023). http://doi.org/10.25135/jcm.98.2311.2975
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