engleski

One-step solid-phase UV spectrophotometric method for phenol determination in vaccines: development and quality assessment

A solid-phase spectrophotometric technique was used to develop very sensitive, inexpensive, one-step procedure for determination of phenol (UV-SPS procedure). The proposed procedure is based on simultaneous sorption of phenol on an anion exchanger, QAE Sephadex A-25 (40 mg), within 10 min at pH 11 and measurement of the intrinsic absorbance of the solid phase in a 1-mm cell at 289 nm and 500 nm, without previous derivatization. The optimum experimental conditions were investigated and comprehensive quality control of the new procedure was carried out using a prevalidation strategy accompanied by a very informative system of diagnosis. The UV-SPS procedure is characterized with both ideal calibration and analytical evaluation function within analyte working range from 0.3 to 3.0 μmol (6.0 to 60.0 nmol mL-1). Random deviations (from ±0.30% to ±5.03%) and systematic deviations (from -2.96% to +4.89) confirmed the favourable precision and accuracy of the UV-SPS method. Evaluated limiting values (LD = 0.049 μmol, LQ = 0.297 μmol) showed that this method enables determination of very low levels of phenol. The sensitivity of UV-SPS procedure is 50 times higher than that provided by the corresponding method in solution. The UV-SPS method was successfully applied to the determination of phenol in vaccines (95.6%-103.4%).

solid-phase spectrophotometric; phenol; vaccines

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