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

Authors
PINA E SOUSA AT BROJO AP
Citation
E. Pina et al., HPLC METHOD DEVELOPMENT AND VALIDATION FOR FORMALDEHYDE IN ENTERIC COATING OF HARD GELATIN CAPSULES, Journal of liquid chromatography, 18(13), 1995, pp. 2683-2693
Citations number
23
Categorie Soggetti
Chemistry Analytical","Biochemical Research Methods
Journal title
Journal of liquid chromatography → ACNP
ISSN journal
01483919
Volume
18
Issue
13
Year of publication
1995
Pages
2683 - 2693
Database
ISI
SICI code
0148-3919(1995)18:13<2683:HMDAVF>2.0.ZU;2-L
Abstract
A reversed-phase high-performance liquid chromatography (HPLC) method for determination of formaldehyde in enteric coating of hard gelatin c apsules is described and fully validated. This method entails the sepa ration of formaldehyde as its 2,4-dinitrophenylhydrazone derivative us ing isocratic solvent eluition and its quantification with appropriate internal standard and ultraviolet detection. The results for selectiv ity, linearity, precision, accuracy and recovery were in agreement wit h validation parameters.