Assay of Diastereoisomers of Cefuroxime Axetil in Amorphous and Crystalline Forms Using UHPLC-DAD

被引：2

作者：

Garbacki, Piotr ^{[1
]}

Tezyk, Artur ^{[2
]}

Zalewski, Przemyslaw ^{[1
]}

Jelinska, Anna ^{[1
]}

Paczkowska, Magdalena ^{[1
]}

Talaczynska, Alicja ^{[1
]}

Oszczapowicz, Irena ^{[3
]}

Cielecka-Piontek, Judyta ^{[1
]}

机构：

[1] Poznan Univ Med Sci, Dept Pharmaceut Chem, Fac Pharm, PL-60780 Poznan, Poland

[2] Poznan Univ Med Sci, Dept Forens Med, PL-60781 Poznan, Poland

[3] Inst Biotechnol & Antibiot, Dept Modified Antibiot, PL-02516 Warsaw, Poland

来源：

CHROMATOGRAPHIA | 2014年 / 77卷 / 21-22期

关键词：

Column liquid chromatography; Cefuroxime axetil; Diastereoisomers; Amorphous and crystalline forms; SOLID-STATE; STABILITY; CEPHALOSPORINS; TABLETS;

D O I：

10.1007/s10337-014-2773-y

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

A sensitive UHPLC-DAD method was developed for determination of diastereoisomers of cefuroxime axetil in bulk substance in amorphous and crystalline forms as well as in pharmaceutical preparations. Chromatographic separation was achieved on Kinetex C-18 (100 mm x 2.1 mm, 1.7 A mu m) column with mobile phase consisting of 0.1 % formic acid:methanol (88:12, v/v), at the flow rate of 0.7 mL min(-1) and total run time of 3 min. The wavelength of the DAD detector was set at 278 nm. Inter-day precision (RSD) was less than 3 % and accuracy level ranged between 98.31 and 104.99 %. Degradation products of cefuroxime axetil in aqueous solutions and in the solid state were identified with a EIS-Q-MS mass spectrometer. The solubility of above-mentioned polymorphic forms of cefuroxime axetil in suitable solvents is a crucial factor during preparation of samples and is essential for chromatographic separation of its diastereoisomers.

引用

页码：1489 / 1495

页数：7