@article{oai:yasuda-u.repo.nii.ac.jp:00000512, author = {西, 博行 and 川畑, 公平 and 稲垣, 昌宣 and 土井, 美歩 and 澤田, 侑里 and Nishi, Hiroyuki and Kawabata, Kohei and Inagaki, Masanori and Doi, Miho and Sawada, Yuri}, issue = {48}, journal = {安田女子大学紀要, Journal of Yasuda Women's University}, month = {Feb}, note = {Recently UHPLC, where smaller particle (2~3 μm) packing materials are employed, is progressing rapidly. Higher performance (higher theoretical plate number, lower theoretical plate height) and fast analysis can be obtained by the UHPLC, compared with the conventional HPLC with the usual size packing materials (5 μm). In this study, core-shell (CS) type packing materials (particle size 2.6 μm, column length 10 cm) are used for the separation of diltiazem (DIL), 8-chlorodilitiazem, and those related substances such as trans-form and deacetyl-form (DIL-OH). Four CS type reversed-phase columns, including a phenyl column and a phenylhexyl column both having a planar moiety, are investigated with the mobile phase containing acetonitrile as an organic solvent. Among four CS type columns, a Cholestyer column gave large Rs values for the separation between isomers such as cis-form (DIL) and its trans-form, n-propyl paraben and isopropyl paraben. On the other hand, separation of DIL and DIL-OH was successful by employing a phenyl column and a phenyl-hexyl column. For the separation of 8-chlorodilitiazem and its related substances, the tendency was the same as in DIL. Finally, assay and content uniformity testing of DIL formulations such as tablets and injections, purity testing (related substances) of DIL drug substances and formulations were successfully performed within 100 s, showing the usefulness of this type column as a tool of high through put analysis.}, pages = {339--350}, title = {平面性を有するコアシェル型逆相カラム-HPLCでのジルチアゼム類の分離選択性と迅速製剤分析法の開発}, year = {2020}, yomi = {ニシ, ヒロユキ and カワバタ, コウヘイ and イナガキ, マサノリ and ドイ, ミホ and サワダ, ユリ} }