Validasi Metoda Analisis Penetapan Kadar Ketoprofen pada Tablet Salut Enterik secara Kromatografi Cair Kinerja Tinggi dan Spektrofotometri UV

Abstract

profen oral dosage forms marketed in Indonesia were mostly enteric-coated tablets. The purpose of this study was to develop and validation high-performance liquid chromatography (HPLC) and direct spectrophotometric method for the analysis of ketoprofen in enteric coated tablets. The assays and content uniformity test of tablets were carried out by an isocratic, reverse-phase HPLC validated method using 5 µm RP-18 column (250 x 4.6 mm), pH 6.5 013 mM phosphate buffermethanol (40:60 v/v) as a mobile phase at a flow rate of 1.0 mL/min and UV detection 258 nm. The developed methods were validated for their linearity, accuracy, precision, limit of detection (LOD) and limit of quantitation (LOQ) in comparison with the UV spectrophotometric method. The HPLC method showed excellent linearity (r > 0.999) in the concentration range of 15 –35 µg/mL. Precision was demonstrated using %RSD < 0.87 and recoveries were good (%R > 99.97). The HPLC method was more sensitive than the UV spectrophotometric, due to the LOD/LOQ values of 0.18/1.20 and 0.67/2.49 µg/mL, respectively. The assays of ketoprofen enteric-coated tablets with the HPLC method were not significantly different from those with the UV spectrophotometric method (P > 0.05