THE SIMULTANEOUS SPECTROPHOTOMETRIC DETERMINATION OF TRIMAZOLIN AND PHENYLEPHRINE HYDROCHLORIDE IN NASAL PREPARATIONS

Abstract

This paper presents the experimental results for the simultaneous spectrophotometric determination of two active components in nasal solutions. The resolution of two-component mixtures of timazolin and phenylephrine has been accomplished by using partial least-squares. The method comprised of the absorptivity measurement in a nasal solution at wavelengths of 265 and 272 nm, respectively. Notwithstanding the presence of two components and their high degree of spectral overlap, they have been determined simultaneously with high accuracy and precision, with no interference, rapidly and without resorting to extraction procedures using non aqueous solvents. This method was tested and validated for various parameters according to ICH guidelines. The results demonstrated that the procedure is accurate, precise and reproducible (relative standard deviation <2 %), while being simple, cheap and less time consuming. The metod was apllied for the analysis of these drug substances in their commercial pharmaceutical formulations.

Keywords

• trimazolin hydrochloride
• phenylephrine hydrochloride
• validation