Pengembangan dan Validasi Metoda Disolusi Tablet Salut Enterik Ketoprofen
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Abstract
Tablet salut enterik Ketoprofen adalah obat yang beredar luas di  Indonesia. Digunakan  untuk mengatasi nyeri arthiritis tulang, rematik dan demam. Namun, sejauh ini uji disolusinya secara spesifik belum tersedia dalam farmakope manapun.  Uji disolusi termasuk parameter yang harus diperhatikan untuk mengetahui kualitas produk obat sediaan padat. Tujuan dari penelitian ini adalah  mengembangkan dan memvalidasi metode pegujian disolusi dari tablet salut enterik ketoprofen. Profil disolusi diamati terhadap 3 produk tablet salut enterik ketoprofen yang beredar di kota Padang. Uji disolusi dilakukan dua tahap menggunakan 750 mL larutan HCl 0,1 N ( tahap asam) dan 1000 mL larutan dapar fosfat pH 6,8 dan 7,4 (tahap basa), alat tipe 1 (keranjang) dan tipe 2 (dayung) kecepatan 50 dan 75 rpm. Hasil uji disolusi selanjutnya ditentukan secara spektrofotometri UV. Metoda uji disolusi  hyperdiscriminating  diperoleh pada uji disolusi menggunakan alat tipe 1,  kecepatan rotasi 75 rpm dan  media disolusi 1000 mL dapar fosfat pH 6,8 dengan nilai Q45 ≥ 75%. Spesifiitas, linieritas  (r = 0,9988), presisi (RSD = 1,12%) dan akurasi (recoveri = 95,7 - 97,6%)  memenuhi syarat keberterimaan sesuai pedoman ICH dan USP. Uji disolusi yang dikembangkan dapat digunakan untuk tujuan pengawasan mutu tablet salut enterik ketoprofen . Â
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