PENETAPAN KADAR PSEUDOEFEDRIN HCL DAN LORATADIN DALAM KOMBINASI SEDIAAN KAPSUL MENGGUNAKAN METODE KLT VIDEO DENSITOMETRI
Keywords:
Kapsul, KLT video densitometri, loratadine, pseudoefedrin HCl, validasi metodeAbstract
Sediaan pseudoefedrin HCl dan loratadine tersedia di perdagangan dalam bentuk kombinasi campuran. Sediaan yang berupa campuran, memerlukan metode analisis dengan perlakuan lanjut sebelum dilakukan pengukuran dikarenakan adanya perbedaan sifat farmakokimia dari zat yang terkandung di dalamnya. Oleh sebab itu diperlukan metode analisis yang akurat, jika memungkinkan sederhana dan murah, untuk menganalisis kandungan sediaan kombinasi tersebut. Salah satu metode yang sederhana yang mampu memberikan hasil yang akurat adalah KLT video densitometri. Tujuan dari penelitian ini untuk memvalidasi metode dalam menetapkan kadar pseudoefedrin HCl dan loratadine dalam sediaan kapsul menggunakan metode KLT video densitometri. Tahapan penelitian meliputi uji kesesuaian sistem menggunakan fase diam plat silika gel GF254 dan fase gerak campuran pelarut metanol-amonia (10mL : 4 tetes, v/v); validasi metode analisis, dan penetapan kadar dalam sediaan yang beredar di pasar. Perekaman gambar dilakukan dibawah lampu UV 255nm menggunakan alat video densitometri dan pengukuran luas dibawah kurva (AUC) dari gambar bercak menggunakan perangkat lunak TLC Analyzer. Penotolan sampel dilakukan secara manual menggunakan pipa kapiler. Hasil pengujian uji kesesuaian sistem diperoleh nilai Rf pseudoefedrin HCl dan loratadine berturut-turut adalah 0,35 dan 0,84. Persamaan kurva kalibarasi untuk pseudoefedrin HCl dan loratadine berturut-turut adalah Y = 0,3003X – 715,94 dan Y = 6,8705X + 222,86. Setelah semua parameter validasi memenuhi persyaratan, diperoleh persen kadar pseudoefedrin HCl dan loratadine dalam sediaan kapsul berturut-turut adalah sebesar 99,42% dan 101%, memenuhi syarat yang ditetapkan dalam Farmakope Indonesia. Nilai-nilai parameter validasi tersebut memenuhi syarat yang telah ditetapkan sehingga metode KLT video densitometri layak untuk digunakan.
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