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
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.