US EPA

8555888 

Journal Article 

HPLC - UV chromatography determination of benzaldehyde arising from benzyl alcohol used as preservative in injectable formulations 

Kashani, HN; Moghaddam, FA; Mehramizi, A 

2012 

5 

2 

98-100 

English 

A simple, rapid, precise and accurate HPLC - UV procedure has been developed to determine benzaldehyde, the toxic oxidation product of the widely used preservative and Co - solvent, benzyl alcohol, in injectable formulations. Benzaldehyde as a main potential impurity of benzyl alcohol may cause many toxic effects such as neurotoxicity, hypersensitivity in human and fatal toxic syndrome in premature infants. Hence, detection and quantification of low level of benzaldehyde in injectable preparations containing benzyl alcohol is necessary. There is Capillary electrophoresis and Gas chromatographic methods for detection and quantification of benzaldehyde but this method are non - compendial and not cost beneficial. The presented HPLC method is rapid and simple in comparison. Separation and quantification are achieved isocratically on Novapak C18 column (250 mm × 4.5 mm, 5 × m i.d.), and UV detection at 254 nm. Equal mixture of acetonitrile and water at a flow rate of 1.2 ml/min was used as mobile phase. 

Benzaldehyde; Benzyl alcohol; Determination; HPLC-UV Chromatography; Injectable formulation