PENETAPAN KADAR AMIODARON HIDROKLORIDA DALAM TABLET MENGGUNAKAN METODE RP HPLC-UV
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amiodaron hidroklorida, formulasi tablet, Rp-HPLC
Abstract
Metode Kromatografi Cair Kinerja Tinggi Fase Balik – Ultra Violet (KCKT FB – UV) telah dikembangkan untuk menentukan kadar amiodaron hidroklorida dalam tablet. Metode kromatografi cair ini menggunakan kolom Shim-pack CLC-ODS column (C18) untuk pemisahan dengan detektor UV pada panjang gelombang 242 nm. Elusi isokratik dilakukan menggunakan fase gerak campuran methanol : asetonitril : buffer (25 mM KH2PO4 + 3 mM H2SO4 + 3,6 mM trietilamina) (63:12:25, v/v/v) dengan laju alir 0,8 mL/menit. Metode analisis divalidasi dengan parameter meliputi limit deteksi, limit kuantitasi, kisaran konsentrasi analisis, presisi, dan akurasi. Hasil validasi menunjukan linearitas yang baik pada kisaran konsentrasi amiodaron hidroklorida 2-10 μg mL-1. Perolehan kembali yang tinggi dan standar deviasi pengukuran yang rendah menunjukkan bahwa metode ini sesuai untuk analisis rutin amiodaron hidroklorida dalam tablet.
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