ISOLATION AND CHARACTERIZATION OF PROCESS RELATED IMPURITY IN CEFUROXIME ACTIVE PHARMACEUTICAL INGRED IENT

Journal: Indo American Journal of Pharmaceutical Sciences (IAJPS) (Vol.4, No. 4)

Publication Date: 2015-05-11

Authors : P. Janaki Pathi; N. Appala Raju;

Page : 790-795

Keywords : Cefuroxime; prep - HPLC; impurities; Mass Spectrometry; NMR; identification and characterization;

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Abstract

The impu rity ranging from 0.08% - 0.12% by peak area in Cefuroxime active pharmaceutical ingredient was detected by simple isocratic reverse - phase high performance liquid chromatogra phy (HPLC). The impurity was isolated by prep - HPLC and characterized by LC - MS/MS an d NMR experimental data. Based on the results obtained from different spectro scopic experiments, the impurity has been characterized as Anti Cefuroximic acid chemically known as [(6R , 7R ) - 3 - [(Acetoxy ) methyl ] - 7 - [(2E) - 2 - furanyl ( methoxyimino) acetyl ] amin o ] - 8 - oxo - 5 - thia - 1 - azabicyclo [4.2.0 ] oct - 2 - ene - 2 - carboxylic acid]. Keywords:

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ISOLATION AND CHARACTERIZATION OF PROCESS RELATED IMPURITY IN CEFUROXIME ACTIVE PHARMACEUTICAL INGRED IENT

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