STUDI PERBANDINGAN METODE UJI DISOLUSI SEDIAAN FAST DISSOLVING FILM AMLODIPIN BESILAT MENGGUNAKAN APARATUS TIPE V DAN METODE FRANZ DIFFUSION CELL
Daftar Isi:
- The research aimed to discover the comparative dissolution profile of dosage forms tested by two different methods by the similarity factor (f1) and difference factor (f2). Dissolution profile of fast amlodipine besilate fast dissolving film and the generic tablets were evaluated using type V apparatus and an alternative method using Franz diffusion cell. Analysis method validation against showed that the analysis method was accurate and precise because the parameters were well within the limits (% recovery of 100.2005 %, %RSD of 0.6096%, and the value of R was 0.9956) with LOD of 0.6727 ppm and LOQ of 2.2425 ppm. The results showed that amlodipine besilate fast dissolving film tested by type V apparatus method and amlodipine besilate fast dissolving film tested by Franz diffusion cell were resulting dimilar dissolution profile with f1 and f2 value of 13.5150 and 53.5018 (f1<15 and f2>50). The comparison of generic tablet amlodipine besilate tested by type V apparatus against generic amlodipine besilate tablet tested by Franz diffusion cell was not being evaluated because the method of Franz diffusion cell is used for transdermal preparations. Statistical analysis showed no significant difference in % release and % DE between preparations tested by apparatus method against the preparations tested by the method of Franz diffusion cell (p > 0.05). These results indicating that alternative methods of Franz diffusion cell method can gives similar dissolution profile with type V apparaatus so that this method of Franz diffusion cell can be used as an alternative simple dissolution testing takes to overcome the problem of tool limitations, especially for small scale testing like in students level.