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
This study reports for the first time about a stability indicating RP-HPLC method for qualitative and quantitative determination of acalabrutinib in bulk and dosage form and in presence its impurities 1, 2 and 3. The chromatographic separation was carried on Zorbax XDB-C18 (250×4.6 ㎜; 5 μ id) as stationary phase, Phosphate buffer pH 6.4 and methanol 80:20 (v/v) as mobile phase at a flow rate of 1.0 mL/min, UV detection was carried at wavelength of 238 ㎚ and the analysis was completed with a run time of 15 min. In these conditions the retention time of acalabrutinib and its impurities 1, 2 and 3 was observed to be 3.50, 4.83, 8.40 and 9.93 min respectively. The method was validated for system suitability, range of analysis, precision, specificity, stability and robustness. Spiked recovery at 50 %, 100 % and 150 % was carried for both standard and impurities and the acceptable % recovery of 98-102 was observed for acalabrutinib and both impurities studied and the % RSD in each spiked level was found to be less than 2. Stability tests were done through exposure of the analyte solution to five different stress conditions i.e expose to 1N hydrochloric acid, 1 N sodium hydroxide, 3 % peroxide, 80 ℃ temperature and UV radiation at 254 nm. In all the degradation condition, standard drug acalabrutinib was detected along with both the impurities studied and the degradation products were successfully separated. In the formulation analysis there is no other chromatographic detection of other impurities and formulation excipients. Hence the developed method was found to be suitable for the quantification of acalabrutinib and can separate and analyse impurities 1 and 2.
목차
Abstract
1. Introduction
2. Materials and Methods
3. Method Validation
4. Results and Discussions
5. Conclusions
References
참고문헌 (12)
참고문헌 신청
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B. K. Harrington, H. L. Gardner, R. Izumi, A. Hamdy, W. Rothbaum, K. R. Coombes, T. Covey, A. Kaptein, M. Gulrajani, B. Van Lith, and C. Krejsa, PLoS One, 11, e0159607 (2016).
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S. E. Herman, A. Montraveta, C. U. Niemann, H. Mora-Jensen, M. Gulrajani, F. Krantz, R. Mantel, L. L. Smith, F. McClanahan, and B. K. Harrington, Clin. Cancer Res., 23, 2831-2841 (2017).
J. Wu, M. Zhang, and D. Liu, J. Hematol. Oncol., 9, 21 (2016).
B. K. Harrington, H. L. Gardner, R. Izumi, A. Hamdy, W. Rothbaum, K. R. Coombes, T. Covey, A. Kaptein, M. Gulrajani, B. Van Lith, and C. Krejsa, PLoS One, 11, e0159607 (2016).
J. J. Buggy and L. Elias, Int. Rev. Immunol., 31, 119-132 (2012).
S. E. Herman, A. Montraveta, C. U. Niemann, H. Mora-Jensen, M. Gulrajani, F. Krantz, R. Mantel, L. L. Smith, F. McClanahan, and B. K. Harrington, Clin. Cancer Res., 23, 2831-2841 (2017).
J. Wu, M. Zhang, and D. Liu, J. Hematol. Oncol., 9, 21 (2016).
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