Micellar liquid chromatographic analysis of benzyl alcohol and benzaldehyde in injectable formulations
An accurate, sensitive and selective reversed-phase micellar liquid chromatographic method was developed for simultaneous determination of benzyl alcohol and benzaldehyde. This method was applied in different injectable formulations containing diclofenac, piroxicam, lincomycin and clindamycin. The method showed excellent linearity in the range of 10-100 μg mL-1 and 1-20 μg mL-1 with the limit of detection (S/N = 3) 0.25 μg mL-1 (2.3 x 10-6 mol L-1) and 0.12 μg mL-1 (1.13 x 10-6 mol L-1) for benzyl alcohol and benzaldehyde, respectively. The suggested method was successfully applied to the analysis of the studied drugs in bulk with average recoveries of 100.1 ± 1.0% for benzyl alcohol and 100.4 ± 1.6% for benzaldehyde, and to the determination of benzyl alcohol and benzaldehyde in injectable formulations with the respective average recoveries of 99.8 ± 0.3 and 100.0 ± 0.4%.
If the inline PDF is not rendering correctly, you can download the PDF file here.
A. G. Kazemifard, D. E. Moore and A. Mohammadi, Polarographic determination of benzaldehyde in benzyl alcohol and sodium diclofenac injection formulations, J. Pharm. Biomed. Anal.30 (2002) 257-262; DOI: 10.1016/S0731-7085(02)00340-0.
M. A. El-Ries, Spectrophotometric and indirect determination of lincomycin by atomic absorption spectroscopy (AAS), Anal. Lett.27 (1994) 1517-1531.
Y. C. de-Micalizzi, N. B. Pappano and N. B. Debattista, First and second order derivative spectrophotometric determination of benzyl alcohol and diclofenac in pharmaceutical forms, Talanta47 (1998) 525-530; DOI: 10.1016/S0039-9140(98)00080-0.
N. Kosmeas and J. T. Clerc, Complete analytical characterization of an antirheumatic injection solution, Pharm. Acta. Helv.66 (1991) 214-218.
K. Urakami, A. Higashi, K. Umemoto and M. Godo, Matrix media selection for the determination of residual solvents in pharmaceuticals by static headspace gas chromatography, J. Chromatogr. A1057 (2004) 203-210.
G. C. Wood, M. R. Iyer, A. M. Geller, A. M. Fleishner and B. B. Sheth, A high pressure liquid chromatography assay method for analysis of deslorelin and benzyl alcohol in deslorelin injection, J. Liq. Chromatogr. Relat. Technol.21 (1998) 2183-2190.
G. N. Menon and B. J. Norris, Simultaneous determination of hydroxyzine hydrochloride and benzyl alcohol in injection solutions by high-performance liquid chromatography, J. Pharm. Sci.70 (1981) 697-698.
United States Pharmacopoeia 27, National Formulary 22, USP Convention, Rockville 2004, p. 2830.
British Pharmacopoeia, Her Majesty's Stationary office, London 1998, pp.161-162.
K. Urakami, C. Kobayashi, Y. Miyazaki, K. Nishijima and Y. Yoshimura, Degradation products generated by sonication of benzyl alcohol, a sample preparation solvent for the determination of residual solvents in pharmaceuticals bulks, on capillary gas chromatography, Chem. Pharm. Bull.48 (2000) 1299-1303.
A. G. Kazemifard, D. E. Moore, A. Mohammadi and A. Kebriyaeezadeh, Capillary gas chromatography determination of benzaldehyde arising from benzyl alcohol used as preservative in injectable formulations, J. Pharm. Biomed. Anal.31 (2003) 685-691; DOI: 10.1016/S0731-7085(02) 00729-X.
D. Gormand, J. Brazier, F. Comet and D. Lecompte, High performance liquid chromatographic determination of benzyl alcohol and its degradation product benzaldehyde in a pharmaceutical cream, J. Chromatogr.355 (1986) 345-349; DOI: 10.1016/S0021-9673(01)97335-2.
M. F. Borgerding and W. L. Hinze, Characterization and evaluation of the use of non-ionic polyoxyethylene (23) dodecanol [Brij 35] micellar mobile phases in reversed-phase high-performance liquid chromatography, Anal. Chem.57 (1985) 2183-2190.
I. I. Hewala, Gas-liquid chromatographic and difference spectrophotometric techniques for the determination of benzaldehyde in benzyl alcohol, J. Pharm. Biomed. Anal.12 (1994) 73-79; DOI: 10.1016/0731-7085(94)80012-X.
I. I. Hewala, Difference spectrophotometric assay of benzaldehyde in benzyl alcohol, Talanta40 (1993) 919-923; DOI: 10.1016/0039-9140(93)80052-S.
A. M. Di-Pietra, V. Cavrini and M. A. Raggi, Determination of benzaldehyde traces in benzyl alcohol by liquid chromatography (HPLC) and derivative UV spectrophotometry, Int. J. Pharm.35 (1987) 13-20.
L. J. Love and J. J. Fett, Optimization of selectivity in micellar chromatographic procedures for the determination of drugs in urine by direct injection, J. Pharm. Biomed. Anal.9 (1991) 323-333; DOI: 10.1016/0731-7085(91)80201-J.
J. C. Miller and J. N. Miller, Errors in Instrumental Analysis; Regression and Correlation, in Statistics for Analytical Chemistry, 3rd ed., Ellis-Horwood, New York 1993, p. 115.