Ultraviolet (UV) Spectrophotometric Analysis of Ketoprofen in Tablets. Statistical Validation of Proposed Method

The absorption spectra of Ketoprofen in the UV domain was plotted using absolute methanol p.a. as a control solvent. The maximum absorption wavelength was determined to be at λ = 254 nm for a ketoprofen solution of 1,4 µg /mL prepared from pure crystalline standard ketoprofen dissolved in methanol p.a. The applied method was the subject of a statistical validation procedure, which consisted in completion of the following stages: the linearity of the method studied over the entire chosen concentration range 2.0 μg / mL - 80.0 μg / mL; detection limit (LD), quantitation limit (LQ), Sandell’s sensitivity, interference of the excipients, stability of prepared standard solutions, method and system precision and accuracy of this method. All statistical parameters were within the normal limits. This analysis method has been statistically validated and can be used anytime and anywhere for UV Ketoprofen spectrophotometric assay in a wide range of samples. The amount of pure ketoprofen assigned on the pharmaceutical tablet was found to be 146.326 mg ketoprofen / tablet. This value was very close to the official declared content of the active substance (150 mg pure ketoprofen/ tablet) set by the official pharmaceutical company, with an average percentage deviation of only 2,45% from the official declared pure content . This calculated value (2,45%) was situated below the maximum percentage error from the official content. of declared active substance (± 5%) imposed by official Pharmacopoeias. So, the pharmaceutical product fully respects the normal official limits provided by the Romanian Pharmacopoeia, 10th Edition and also by the European and International Pharmacopoeias rules.