PROFIL DISOLUSI IN VITRO TABLET LEVOFLOKSASIN GENERIK DAN LEVOFLOKSASIN NON GENERIK
DOI:
https://doi.org/10.30595/pji.v7i1.543Abstract
ABSTRAK Levofloksasin merupakan antibiotik berspektrum luas golongan kuinolon. Levofloksasin digunakan untuk mengobati infeksi bakteri yang terjadi di saluran pernafasan, saluran kencing dan kulit. Hingga saat ini Levofloksasin belum terdaftar dalam monografi USP, sehingga belum memiliki metode disolusi yang pasti. Uji disolusi in vitro sangat penting untuk memastikan kualitas suatu produk obat dengan cara melihat profil pelepasan obat dalam medium pembawanya dan untuk memperkirakan profil disolusi obat yang terjadi didalam tubuh. Penelitian ini bertujuan untuk membandingkan profil disolusi tablet Levofloksasin dalam medium HCl 0,1 N dan dalam medium dapar fosfat pH 7,4, serta untuk membandingkan profil disolusi antara tablet Levofloksasin generik dengan non generik. Uji disolusi menggunakan metode pengaduk tipe dayung, medium HCl 0,1 N atau dapar fosfat pH 7,4 sebanyak 900 ml, suhu dijaga pada 37±0,5°C, dengan kecepatan perputaran 50 rpm. Sampel diambil (5 ml) pada menit ke 5, 10, 20, 30 dqn 45 dan volume yang diambil digantikan dengan medium yang baru. Sampel kemudian dibaca serapannya dengan spektrofotometer pada λ maksimum. Hasil uji disolusi menunjukkan bahwa konsentrasi obat Levofloksasin yang dilepaskan mencapai lebih dari 80% pada menit ke 45. Profil disolusi Levofloksasin dalam medium HCl 0,1 N lebih baik dari pada profil disolusi Levofloksasin dalam medium dapar fosfat pH 7,4, dan tidak ada perbedaan yang signifikan antara tablet Levofloksasin generik dengan non generik. Kata kunci : profil disolusi, in vitro, levofloksasin ABSTRACT Levofloxacine is an antibiotic broad spectrum of quinolon. It has been used to treat bacterial infections in respiratory tract, urinary tract, and skin. Till in this time Levofloxacine no in monograph in USP, hence not yet owned definitive dissolution method. The in vitro dissolution testing very important to ensure quality of drug product with show that drug release in this solvent and to the prediction of in vivo performance. This research was proposed to compare dissolution profile Levofloxacine tablet in HCl 0.1 N medium and Phosphat buffer of pH 7.4, and also to compare profile dissolution of generic Levofloxacine with non generic one. In the dissolution testing used paddle methode. Medium was 900 ml of HCl 0.1 N and Phosphat buffer of pH 7.4 at 37± 0.5°C with a speed 50 rpm. Sample aliquots (5 mL) were withdrawn at 5, 10, 20, 30 and 45 minutes and replaced with equal volumes of fresh medium. Sample was absorbed with spectrophotometrically at λ max. The results of dissolution showed that the drug concenrations of Levofloxacine reaching more than 80% is released over 45 minutes. Dissolution profile of Levofloxacine in HCl 0.1 N medium better than Levofloxacine in Phosphat buffer of pH 7.4 medium and no significantly differences between generic Levofloxacine with non generic Levofloxacine. Key words : dissolution profile, in vitro, levofloxacine.References
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