Abstract
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.
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