Validation of HPLC method for quantitative determination of Tinosorb®S and three other sunscreens in a high protection cosmetic product

A chromatographic method (high performance liquid chromatography) with a diode array detector was developed for simultaneous assay of Tinosorb S (bis-ethylhexyloxyphenol methoxyphenyl triazine) with three other sunscreen agents [benzophenone-3, butyl methoxydibenzoylmethane (avobenzone) and ethylhexyl methoxycinnamate] in high protection sunscreen. Separations were performed on a RP-18 Nucleodur Gravity column (150 x 4.6 mm, 5 mum) eluted with a ternary gradient mixture constituted of tetrahydrofuran, acetonitrile and an aqueous solution of acetic acid. The quantitative analysis was achieved with internal calibration performed with octyl dimethyl para-aminobenzoate (PABA) at 330 nm. In accordance with the analytical references (SFSTP, ICH, ISO...), the accuracy of the method was evaluated using a statistical approach of the validation parameters (specificity, response function, linearity, precision and trueness). For each studied ultraviolet filter, an accuracy profile was determined on a predicted range. These profiles show a graphical representation of the recovery percentage and confidence limits centred on 100%. The method is validated and can be used for analysis in cosmetic sunscreen products.