Optimasi Metode KCKT untuk Penetapan Kadar 4-Isobutilasetofenon dan 2-(4-Isobutirilfenil) Asam Propanoat dalam Tablet Ibuprofen
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Pendahuluan: Ibuprofen (IBP) banyak digunakan sebagai obat anti piretik dan pereda nyeri, obat ini sensitif terhadap oksidasi dan suhu. Cemaran IBP yang keberadaannya dalam tablet harus memenuhi syarat uji batas adalah 4-isobutilasetofenon (IBP RC C) dan 2-(4-isobutirilfenil) asam propanoat (IBP RC J). Variasi matriks tablet seringkali membuat prosedur standar untuk analisis cemaran perlu dioptimasi karena dapat menyebabkan kinerja kromatografi yang tidak memenuhi syarat kompendia. Tujuan: Penelitian ini bertujuan untuk memperoleh kolom dan kondisi operasional KCKT yang selektif, efisien dan memenuhi persyaratan kompendia untuk pengujian IBP dan cemarannya. Metode: Penelitian ini dirancang untuk membandingkan kinerja kromatografi (resolusi, faktor ikutan dan jumlah lempeng teoritis) beberapa kolom KCKT C18 yang sesuai persyaratan United States Pharmacopoeia (USP) untuk penetapan cemaran organik dalam tablet ibuprofen. Instrumen KCKT yang digunakan adalah Shimadzu Prominence dengan detektor Photo Diode Array (PDA). Kondisi analisis optimum yang diperoleh diaplikasikan untuk analisis 3 macam sediaan tablet IBP. Hasil: Kondisi optimum diperoleh melalui kolom C18-C 4,6 x 250 mm, 5 µm, menggunakan fase gerak larutan asam kloroasetat 1% pH 3,0 : asetonitril (45:55, v/v), laju alir 1,5 mL/menit, suhu kolom ambient, detektor PDA 254 nm, volume injeksi 10 µL dengan waktu analisis 11 menit. Diperoleh puncak-puncak yang simetris dengan kinerja kromatografi yang memenuhi persyaratan USP. Kesimpulan: Metode yang telah dioptimasi berhasil diaplikasikan pada 3 sediaan tablet yang beredar di pasaran dan dapat digunakan untuk pengujian rutin dalam rangka pengawasan kualitas produk obat tablet ibuprofen.
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