Validasi Metode Analisis KCKT untuk Penetapan Kadar Parasetamol dalam Sediaan Tablet Generik dan Bermerek
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Latar Belakang: Parasetamol merupakan obat analgesik dan antipiretik yang paling banyak digunakan, sehingga pengendalian mutu sediaannya penting untuk menjamin efektivitas terapi. Tujuan: Penelitian ini bertujuan untuk memvalidasi metode Kromatografi Cair Kinerja Tinggi (KCKT) yang sederhana, cepat, dan andal untuk penetapan kadar parasetamol dalam sediaan tablet generik dan bermerek. Metode: Analisis dilakukan menggunakan kolom C18 dengan fase gerak campuran air dan metanol (3:1, v/v), laju alir 1,0 mL.menit–1, volume injeksi 20 µL, dan deteksi pada panjang gelombang 243 nm. Parameter validasi yang diuji meliputi kesesuaian sistem, linearitas, akurasi, presisi, batas deteksi (LOD), dan batas kuantifikasi (LOQ) sesuai pedoman farmakope. Hasil: Metode menunjukkan linearitas sangat baik pada rentang 8–12 µg.mL–1 (r = 0,9998) dengan nilai LOD 0,13 µg.mL–1 dan LOQ 0,40 µg.mL–1. Nilai akurasi sebesar 99,00% untuk tablet generik dan 98,86% untuk tablet bermerek, sedangkan presisi menunjukkan %RSD 0,53% dan 0,68%. Kadar parasetamol yang diperoleh adalah 101,47% dan 100,20% untuk tablet generik dan bermerek, sesuai dengan standar farmakope (90–110%). Kesimpulan: Metode KCKT yang divalidasi terbukti akurat, presisi, dan sensitif untuk penetapan kadar parasetamol dalam sediaan tablet. Metode ini layak digunakan untuk pengujian rutin mutu obat dan dapat dikembangkan untuk uji stabilitas maupun studi farmakokinetik.
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