validasi metoda analisis penetapan kadar secara kromatografi cair kinerja tinggi (KCKT) dan spektrofotometri UV serta pengembangan uji disolusi tablet salut enterik ketoprofen

saafrida, saafrida (2021) validasi metoda analisis penetapan kadar secara kromatografi cair kinerja tinggi (KCKT) dan spektrofotometri UV serta pengembangan uji disolusi tablet salut enterik ketoprofen. Masters thesis, universitas andalas.

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Abstract

Ketoprofen oral dosage form marketed in Indonesia were mostly enteric coated tablets. However, the analytical methods for the assay and dissolution test are not yet available in the compendial. The purpose of this study was to develop the high performance liquid chromatography (HPLC) and direct UV spectrophotometric methods for the analysis of ketoprofen enteric coated tablets. The assays and content uniformity test of tablets were carried out by an isocratic, reverse-phase HPLC validated method using 5µm RP-18 column (250 x 4.6 mm), pH 6.5 13mM phosphate buffer-methanol (40:60 v/v) as a mobile phase at a flow rate of 1.0 mL/min and UV detection 258 nm. The HPLC method showed excellent linearity (r² > 0.999) in the concentration range of 15 –35 µg/mL. Precision (%RSD < 0.87 ) and recoveries (%R > 99.97 )were good . The LOD and LOQ resulted from HPLC and UV spectrophotometric methods were 0.18 and 0.67 µg/mL respectively (LOD); 1.20 and 2.49 µg/mL, respectively (LOQ). The assays of ketoprofen enteric coated tablets with the HPLC method was not significantly different from those with the spectrophotometric method (P > 0.05). A dissolution test was developed and validated using direct UV spectrophotometric method. A discriminatory dissolution method with Q45 ≥ 75% was given by the method using USP apparatus 1 (basket) at rotation speed 75 rpm and 1000 mL deaerated pH 6.8 phosphate buffer as the dissolution medium . The method was validated for specificity, linearity, accuracy and precision according USP and ICH guidelines. The validated dissolution test was sufficient to meet the requirements and could be applied for quality control of ketoprofen enteric coated tablets.

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