期刊
SEPARATIONS
卷 7, 期 3, 页码 -出版社
MDPI
DOI: 10.3390/separations7030047
关键词
chiral chromatography; COVID-19; enantioseparation; ICH guidelines; pharmaceutical formulations; quantitative analysis; system suitability parameters
资金
- grant on classical Hodgkin lymphoma to Enrico Tiacci from AIRC (IG 2019) [23732]
In this paper, two new reversed-phase (RP) HPLC-UV methods enabling the quantitative achiral and chiral analysis of ruxolitinib in commercial tablets (containing 20 mg of active pharmaceutical ingredient, API) and not commercially available galenic capsules (with 5 mg of API) are described. For the achiral method based on the use of a water/acetonitrile [70:30,v/v; with 0.1% (v) formic acid] eluent, a research validation study was performed mostly following the International Council for Harmonization guidelines. All the system suitability parameters were within the acceptance criteria: tailing factor, between 1.7 and 2.0; retention factor, 2.2; number of theoretical plates, >9000. The linearity curve showed R-2= 0.99 (R-xv(2)= 0.99), while trueness (expressed as recovery) was between 96.3 and 106.3%. Coefficient of variations (CVs) (repeatability: CV(w)and intermediate precision: CVIP) did not exceed 1.3% and 2.9%, respectively. Moreover, the use of the enantiomeric Whelk-O1 chiral stationary phases operated under similar RP eluent conditions as for the achiral analyses, and the inverted chirality columns approach (ICCA) allowed us to establish that the enantiomeric purity of ruxolitinib is retained upon reformulation from tablets to capsules. The two developed methods can allow accurate determinations of ruxolitinib in drug formulations for medical use.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据