An isocratic reversed-phase high-performance liquid chromatographic method for the simultaneous determination of benzoyl peroxide and the related compounds benzoic acid, benzaldehyde, ethyl benzoate, methylparaben, and propylparaben in dermal preparations.
A reversed-phase high-performance liquid chromatographic method was developed for the simultaneous determination of benzoyl peroxide and the related compounds benzoic acid (BA), methylparaben, benzaldehyde, propylparaben, and ethyl benzoate. The compounds are separated on a column containing octadecyl silane chemically bonded to porous silica particles. The mobile phase is acetonitrile-buffer (45 + 55, v/v). Solutions are injected into the chromatographic system under isocratic conditions at a constant flow rate of 1.5 mL/min with UV detection at 235 nm. Analysis of stability samples showed rapid accumulation of BA by thermal degradation. A rationale has been established for the acceptable limit of BA in the formulation, which already contains BA (0.2%) as a preservative. The proposed method is efficient and determines the active compound and 5 related compounds in a run time of 20 min. The method was validated according to the guidelines of the International Conference on Harmonization and demonstrated good agreement with the validation requirements.
Ali
Mohammed Shahid
MS
Jamjoom Pharmaceuticals Co. Ltd, Jeddah, Saudi Arabia. msali26@rediffmail.com
Rafiuddin
Syed
S
Munir
Muhammad Imran
MI
Ghori
Mohsin
M
Khatri
Aamer Roshanali
AR
D001547:Benzaldehydes / Q000032:analysis; D001565:Benzoates / Q000032:analysis; D019817:Benzoic Acid / Q000032:analysis; D001585:Benzoyl Peroxide / Q000031:analogs & derivatives* / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D002855:Chromatography, Thin Layer; D003879:Dermatologic Agents / Q000032:analysis*; D007202:Indicators and Reagents; D007641:Keratolytic Agents / Q000032:analysis*; D010226:Parabens / Q000032:analysis; D012015:Reference Standards; D012996:Solutions / Q000032:analysis; D013055:Spectrophotometry, Infrared
D001547:Benzaldehydes; D001565:Benzoates; D003879:Dermatologic Agents; D007202:Indicators and Reagents; D007641:Keratolytic Agents; D010226:Parabens; D012996:Solutions; D019817:Benzoic Acid; C015358:methylparaben; C032175:benzaldehyde; D001585:Benzoyl Peroxide; C006068:propylparaben