Authors: Soo Hyun Park, Sylvia Grosse, Mauro De Pra, Frank Steiner
Thermo Fisher Scientific, Germering, Germany
Keywords: Cefprozil, cefprozil related impurity, Ph. Eur. method, HPLC, Vanquish Core, Hypersil GOLD aQ, European Pharmacopeia, impurity, system suitability
Application benefits
• The method for impurities quantification of cefprozil monohydrate according to Ph. Eur. monograph was successfully implemented on a Thermo Scientific™ Hypersil GOLD™ aQ column.
• The method is suitable for drug substance impurity analysis, without any adjustment.
• The Thermo Scientific™ Vanquish™ Core HPLC system provides excellent repeatability for retention time and peak area, as well as peak symmetry.
Goal
To demonstrate the European Pharmacopoeia based analysis of impurities in cefprozil with the new Vanquish Core HPLC system.
Introduction
Cefprozil is a second generation, broad-spectrum oral cephalosphorin antibiotic. It belongs to b-lactam antibiotics with anti-bacterial activity.1 Cefprozil works by inhibiting bacterial septum and cell wall synthesis formation due to the binding to penicillin-binding proteins (PBPs) in the bacterial cytoplasmic membrane.2 It is used to treat respiratory tract, skin, and ear infections, acute and chronic bronchitis, and other bacterial infections.1 Cefprozil consists of a mixture of the two diastereoisomers (i.e., Z- and E- isomers), and the Z-isomer is mainly responsible for the antibiotic activity.1 The chemical structure of cefprozil is presented in Figure 1.
Levels of impurities present in drug substances or formulation are strictly regulated by authorities such as the International Council for Harmonisation (ICH) and the U.S. Food and Drug Administration (FDA).3 Based on the recommended daily dose of 1000 mg cefprozil,4 reporting, identification, and quantitation limits of cefprozil impurities according to ICH guidelines are, in order, 0.05%, 0.1%, and 0.15%5.
In this work, a method for the analysis of cefprozil related impurities is performed using a Vanquish Core high performance liquid chromatography (HPLC) system. The method is based on the cefprozil monohydrate European Pharmacopoeia (Ph. Eur.) monograph6 and is suitable for impurity analysis for batch-release or stability evaluation. The Vanquish Core HPLC system delivers excellent retention time and peak area precision, whereby reliable results are generated.