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
오류제보하기
The presence of process related impurities in any drug or the drug product was associated with its safety, stability and efficacy. The overall literature survey proved that there is no method published on the assessment of process related impurities in brigatinib. In this study, a simple, reliable and stable HPLC qualitative method was reported for quantification of process related impurities with easy and quick extraction procedure. The impurities along with standard brigatinib was resolved on Lichrospher<SUP>®</SUP>C18 (250 mm × 4.6 mm; 5 μm particle size) column in room temperature using methanol, acetonitrile, pH 4.5 phosphate buffer in 55:25:20 (v/v) at 1.0 mL/min as mobile phase and UV detection at 261 nm. The method produces well resolved peaks at retention time of 4.60 min, 12.28 min, 3.37 min, 7.34 min and 8.39 min respectively for brigatinib, impurity A, B, C and D. The method produces a very sensitive detection limit of 0.0065 μg/mL, 0.0068 μg/mL, 0.0053 μg/mL and 0.0058 μg/mL for impurity A, B, C and D respectively with calibration curve linear in the concentration range of 22.5-135 μg/mL for brigatinib and 0.0225-0.135 μg/mL for impurities. The method produces all the validation parameters under the acceptable level and doesn’t produces any considerable changes in peak area response while minor changes in the developed method conditions. The method can effectively resolve the unknown stress degradation products along with known impurities with less % degradation. The method can efficiently resolve and quantify the impurities in formulation and hence can suitable for the routine quality analysis of brigatinib in raw material and formulation.
목차
Abstract
1. Introduction
2. Experimental
3. Results and Discussion
4. Conclusions
References
참고문헌 (18)
참고문헌 신청
N. Djajić, J. Krmar, M. Rmandić, M. Rašević, B. Otašević, M. Zečević, A. Malenović, and A. Protić, J. Chromatogr. A., 2, 100023 (2022). https://doi.org/10.1016/j.jcoa.2021.100023
L. Liu, A. Mouallem, K. P. Xiao, and J. Meisel, J. Pharm. Biomed. Anal., 194, 113760 (2021). https://doi.org/10.1016/j.jpba.2020.113760
D. T. Manallack, SAR. QSAR. Environ. Res., 20, 611-655 (2009). https://doi.org/10.1080/10629360903438313
W. S. Huang, S. Liu, D. Zou, M. Thomas, Y. Wang, and T. Zhou, J. Med. Chem, 59(10), 4948-4964 (2016). https://doi.org/10.1021%2Facs.jmedchem.6b00306
S. Rashdan and D. E. Gerber, Transl. Cancer. Res., 6, 78-82 (2017). https://doi.org/10.21037/tcr.2017.02.12
L. Liu, A. Mouallem, K. P. Xiao, and J. Meisel, J. Pharm. Biomed. Anal., 194, 113760 (2021). https://doi.org/10.1016/j.jpba.2020.113760
D. T. Manallack, SAR. QSAR. Environ. Res., 20, 611-655 (2009). https://doi.org/10.1080/10629360903438313
W. S. Huang, S. Liu, D. Zou, M. Thomas, Y. Wang, and T. Zhou, J. Med. Chem, 59(10), 4948-4964 (2016). https://doi.org/10.1021%2Facs.jmedchem.6b00306
S. Rashdan and D. E. Gerber, Transl. Cancer. Res., 6, 78-82 (2017). https://doi.org/10.21037/tcr.2017.02.12
이 논문의 저자 정보
이 논문과 함께 이용한 논문
Label-free and sensitive detection of purine catabolites in complex solutions by surface-enhanced raman spectroscopy
Batmend Davaa-Ochi
,
I
,
is Baffou
외 4명
한국표면공학회지
2022
.12
VOx/WO3-TiO₂ SCR 촉매의 바나듐 표면밀도 조절에 따른 탈질효율 증진 연구
신중훈
,
최경륜
,
홍성창
한국대기환경학회지(국문)
2019
.12
Determination of Ethanol in Blood Samples Using Partial Least Square Regression Applied to Surface Enhanced Raman Spectroscopy
Güneş Açikgöz
,
Be
,
na Hamamci
외 2명
Toxicological Research
2018
.04
Photopolymerization of UV Curable Coatings Monitored by Raman Spectroscopy
Fengguo Liu
,
Ying Wang
,
Xiangxin Xue
외 1명
폴리머
2016
.05
최근 본 자료
댓글(0)
0
UCI(KEPA) : I410-ECN-0102-2023-433-001946382