Validasi Metoda Analisis Penetapan Kadar Ketoprofen pada Tablet Salut Enterik secara Kromatografi Cair Kinerja Tinggi dan Spektrofotometri UV
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Abstract
Ketoprofen yang beredar di Indonesia sebagian besar dalam bentuk sediaan tablet salut enterik, tetapi metoda analisis untuk penetapan kadar dan uji disolusinya belum tersedia dalam farmakope. Tujuan dari penelitian ini adalah mengembangkan metode kromatografi cair kinerja tinggi (KCKT) dan spektrofotometri ultraviolet visibel (UV) untuk melakukan analisis tablet salut enterik ketoprofen. Penetapan kadar dan keseragaman kandungan ketoprofen tablet salut enterik ditentukan secara KCKT isokratik fase terbalik yang telah divalidasi menggunakan kolom reverse phase (RP-18 ) (250 x 4,6 mm) diameter partikel 5 µm, fase gerak metanol-dapar fosfat 13 mM pH 6,5 perbandingan 60:40 v/v, laju alir 1,0 mL/menit dan detektor UV 258 nm. Spesifisitas, linieritas, akurasi, dan presisi memenuhi persyaratan International Conference on Harmonization (ICH). Metode KCKT memberikan lineritas yang sangat baik (r > 0,999) pada rentang konsentrasi 15 – 35 µg/mL, presisi dinyatakan dalam persen deviasi standar relative (% RSD <0,87) dan perolehan kembali yang baik (R> 99,97%). Metode KCKT lebih sensitif dibandingkan metode spektrofotometri UV, dengan nilai LOD masing-masing adalah 0,18 dan 0,67 µg/mL serta LOQ 1,20 dan 2,49 µg/mL. Hasil validasi dan uji penetapan kadar ketoprofen pada tablet salut enterik dengan metode KCKT tidak berbeda nyata dibandingkan dengan metode spektrofotometri UV (P>0,05)
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