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Published in

Elsevier, Journal of Pharmaceutical and Biomedical Analysis, 4(31), p. 685-691

DOI: 10.1016/s0731-7085(02)00729-x

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Capillary gas chromatography determination of benzaldehyde arising from benzyl alcohol used as preservative in injectable formulations

Journal article published in 2003 by Amir G. Kazemifard, Douglas E. Moore, A. Mohammadi ORCID, A. Kebriyaeezadeh
This paper is available in a repository.
This paper is available in a repository.

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Abstract

A simple, precise and accurate capillary gas-liquid chromatographic procedure has been developed to determine benzaldehyde, the toxic oxidation product of the widely used preservative and co-solvent benzyl alcohol, in injectable formulations of the non-steroidal anti-inflammatory drugs, diclofenac and piroxicam, as well as in Vitamin B-complex injection solutions. Following liquid-liquid extraction with chloroform, separation and quantification are achieved on a fused silica capillary column (25 m x 0.53 mm i.d.) coated with 0.5 microm film of OV-101. 3-Chlorobenzaldehyde was used as internal standard with flame-ionization as the detection mode. The ability of the system to resolve benzaldehyde peak from interfering components is good. The method displays excellent linearity over the concentration range 0.5-100 microg/ml of benzaldehyde and a precision of better than 2.5% from intra- and inter-day analyses. The quantification limit for benzaldehyde is 0.4 microg/ml. Levels of benzaldehyde in generic diclofenac and piroxicam injection formulations were found to be seven to 15 times higher than in reference formulations, and double in generic Vitamin B-complex injection formulations.