Romanian Society of Pharmaceutical Sciences

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THE VALIDATION OF THE UV SPECTROPHOTOMETRIC METHOD FOR THE ASSAY OF 5 FLUOROURACIL

ILEANA CORNELIA COJOCARU*, LACRAMIOARA OCHIUZ, ADRIAN SPAC, GRATIELA POPA, LAURA PALADE, IULIANA POPOVICI

The University of Medicine and Pharmacy ”Gr. T. Popa”, Iasi, The Faculty of Pharmacy, Pharmaceutical Technology Department, Str. Universitatii nr. 16, 700115, Iasi, Romania

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In order to determine the release profile of 5 – fluorouracil (5-FU) from modern pharmaceutical dosage forms with vaginal administration during in vitro dissolution tests, an UV spectrophotometric assay method was developed, in acetate buffer solution (pH = 4.3). The working conditions were established with an absorbance maximum at λ = 266 nm. The method was validated by determining the following parameters: the linearity in the chosen concentration domain (1.02 to 20.40 μg/mL), the correlation coefficient r2 = 0.9992, the detection limit (LD) was 0.59 μg/mL, the quantification limit (LQ) was 1.79 μg/mL, the precision of the method (RSD = 0.5176 %), the intermediate precision of the method (RSD = 0.5521 %) and the accuracy of the method for which we obtained a mean recovery of 99.95%. In conclusion, this assay method for 5 - FU is simple, easy to apply, sensitive, linear, precise and accurate.