HPLC METHOD DEVELOPMENT AND VALIDATION FOR FORMALDEHYDE IN ENTERIC COATING OF HARD GELATIN CAPSULES

被引：9

作者：

PINA, E

SOUSA, AT

BROJO, AP

机构：

[1] Laboratory of Pharmaceutical Technology, University of Coimbra, Coimbra

来源：

JOURNAL OF LIQUID CHROMATOGRAPHY | 1995年 / 18卷 / 13期

关键词：

D O I：

10.1080/10826079508009318

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

A reversed-phase high-performance liquid chromatography (HPLC) method for determination of formaldehyde in enteric coating of hard gelatin capsules is described and fully validated. This method entails the separation of formaldehyde as its 2,4-dinitrophenylhydrazone derivative using isocratic solvent eluition and its quantification with appropriate internal standard and ultraviolet detection. The results for selectivity, linearity, precision, accuracy and recovery were in agreement with validation parameters.

引用

页码：2683 / 2693

页数：11

共 23 条

[1] DETERMINATION OF FORMALDEHYDE IN GAS MIXTURES BY CHROMOTROPIC ACID METHOD [J].