AZITHROMYCIN 500 MG

MEDIUM BUFFER FOSFAT 6,0

Zithromax 500 (429-64004) Azithromycin 500 MG ( B-Zifin-35 LT) Azithromycin 500 MG ( 20220217 )
sampel konsentrasi sampel konsentrasi sampel konsentrasi
0 10 15 30 45 60 0 10 15 30 45 60 0 10 15 30
Zithromax 500 1 0 71.06 117.86 112.78 120.23 120.48 Zifin 500-1 0 94.15 94.08 105.20 106.10 99.86 Zifin 500-1 0 70.48 100.02 72.50
Zithromax 500 2 0 95.60 104.68 105.54 115.87 114.93 Zifin 500-2 0 92.33 98.44 93.81 104.78 102.63 Zifin 500-2 0 70.32 97.76 72.50
Zithromax 500 3 0 0.00 0.00 0.00 0.00 0.00 Zifin 500-3 0 0.00 0.00 0.00 0.00 0.00 Zifin 500-3 0 0.00 0.00 0.00
Zithromax 500 4 0 0.00 0.00 0.00 0.00 0.00 Zifin 500-4 0 0.00 0.00 0.00 0.00 0.00 Zifin 500-4 0 0.00 0.00 0.00
Zithromax 500 5 0 0.00 0.00 0.00 0.00 0.00 Zifin 500-5 0 0.00 0.00 0.00 0.00 0.00 Zifin 500-5 0 0.00 0.00 0.00
Zithromax 500 6 0 0.00 0.00 0.00 0.00 0.00 Zifin 500-6 0 0.00 0.00 0.00 0.00 0.00 Zifin 500-6 0 0.00 0.00 0.00
Zithromax 500 7 0 0.00 0.00 0.00 0.00 0.00 Zifin 500-7 0 0.00 0.00 0.00 0.00 0.00 Zifin 500-7 0 0.00 0.00 0.00
Zithromax 500 8 0 0.00 0.00 0.00 0.00 0.00 Zifin 500-8 0 0.00 0.00 0.00 0.00 0.00 Zifin 500-8 0 0.00 0.00 0.00
Zithromax 500 9 0 0.00 0.00 0.00 0.00 0.00 Zifin 500-9 0 0.00 0.00 0.00 0.00 0.00 Zifin 500-9 0 0.00 0.00 0.00
Zithromax 500 10 0 0.00 0.00 0.00 0.00 0.00 Zifin 500-10 0 0.00 0.00 0.00 0.00 0.00 Zifin 500-10 0 0.00 0.00 0.00
Zithromax 500 11 0 0.00 0.00 0.00 0.00 0.00 Zifin 500-11 0 0.00 0.00 0.00 0.00 0.00 Zifin 500-11 0 0.00 0.00 0.00
Zithromax 500 12 0 0.00 0.00 0.00 0.00 0.00 Zifin 500-12 0 0.00 0.00 0.00 0.00 0.00 Zifin 500-12 0 0.00 0.00 0.00
rata-rata 0 83.33 111.27 109.16 118.05 117.71 rata-rata 0 93.24 96.26 99.51 105.44 101.25 rata-rata 0 70.40 98.89 72.50
SD 17.3524 9.3197 5.1195 3.0830 3.9244 SD 1.2869 3.0830 8.0539 0.9334 1.9587 SD 0.1131 1.5981 0.0000
RSD 20.8237 8.3757 4.6899 2.6116 3.3341 RSD 1.3802 3.2028 8.0940 0.8852 1.9346 RSD 0.1607 1.6160 0.0000
sum 539.52 sum 495.69 sum 427.36

Zithromax 500 VS B-Zifin-35 LT Zithromax 500 VS 20220217

10 15 30 45 60 sum 10 15 30 45 60 sum
min -9.91000 15.01000 9.65500 12.61000 16.46000 min 12.93000 12.38000 36.66000 16.85000 33.33500
abs 9.91000 15.01000 9.65500 12.61000 16.46000 63.64500 abs 12.93000 12.38000 36.66000 16.85000 33.33500 112.15500
kuadrat 98.20810 225.30010 93.21903 159.01210 270.93160 846.67093 kuadrat 167.18490 153.26440 1343.95560 283.92250 1111.22223 3059.54963

f1 11.797 f1 20.788
f2 44.217 f2 30.315

AZITHROMYCIN 500 MG
140
PERSEN DISOLUSI

120 118.05
117.71
111.27
109.16
105.44
100 98.89 99.51 101.20 101.25
96.26
93.24
84.37 83.33
80
72.50 Zithromax 500 (429-64004)
70.40
 140

PERSEN DISOLUSI
120 118.05
117.71
111.27
109.16
105.44
100 98.89 99.51 101.20 101.25
96.26
93.24
84.37 83.33
80
72.50 Zithromax 500 (429-64004)
70.40
Azithromycin 500 MG ( B-Zifin-35 LT)
60
Azithromycin 500 MG ( 20220217 )

40

20

0 0
0 20 40 60 80 100 120 140
WAKTU ( MENIT )
Percentage Dissolution

Dissolution Profile Ciproxin®500

Media HCl 0.01 N
(Ciprofloxacin 500)
130
120 Zithromax 500 1
110 Zithromax 500 2
100 Zithromax 500 3
90 Zithromax 500 4
80 Zithromax 500 5
70 Zithromax 500 6
60 Zithromax 500 7
50 Zithromax 500 8
40 Zithromax 500 9
30 Zithromax 500 10
20 Zithromax 500 11
10 Zithromax 500 12
0
0 10 20 30 Time 40 50 60 70
 70 Zithromax 500 6
60 Zithromax 500 7
50 Zithromax 500 8
40 Zithromax 500 9
30 Zithromax 500 10
20 Zithromax 500 11
10 Zithromax 500 12
0
0 10 20 30 Time 40 50 60 70
Percentage Dissolution

Dissolution Profile Rindoflox 500

Media HCl 0,01 N
(Ciprofloxacin 500)

110
Zifin 500-1
100
Zifin 500-2
90
Zifin 500-3
80
Zifin 500-4
70
Zifin 500-5
60
Zifin 500-6
50
Zifin 500-7
40
Zifin 500-8
30
Zifin 500-9
20
Zifin 500-10
10
Zifin 500-11
0
0 10 20 30 40 50 60 70 Zifin 500-12
Time
Percentage Dissolution

Dissolution Renator®500
Media HCl 0,01 N
(Ciprofloxacin 500)

15

10

0
0 2 4 6 8 10 12
Time
5

0
0 2 4 6 8 10 12
Time
 45 60
105.76 100.65
96.64 68.09
0.00 0.00
0.00 0.00
0.00 0.00
0.00 0.00
0.00 0.00
0.00 0.00
0.00 0.00
0.00 0.00
0.00 0.00
0.00 0.00
101.20 84.37
6.4488 23.0234
6.3723 27.2886
PERHITUNGAN STATISTIK
UNTUK PROFIL DISOLUSI TERBANDING Dovapro vs Iretensa vs Aprovel
Larutan Dapar HCl pH 1,2 Pendayung 75 rpm (Irbesartan)

Waktu disolusi (Menit)

STINATOR 10 15 30 45 60 Min Abs
R1 44.86 48.00 52.31 59.56 76.49 0.0064 0.0064166667
R2 45.17 49.03 53.42 59.88 75.98 -0.063 0.0626666667
R3 45.73 48.91 54.23 60.87 75.77 0.068 0.0681666667
R4 45.00 48.89 52.09 59.87 76.73 -0.237 0.2369166667
R5 45.01 48.89 52.30 60.19 76.13 -0.495 0.4950833333
R6 45.16 48.83 54.69 60.34 75.94 Sum 0.86925
R7 45.00 48.00 54.89 61.20 76.95
R8 45.25 49.03 54.95 58.99 77.49 f1 0.3070596
R9 45.65 48.91 51.91 58.00 76.95
R10 45.12 48.89 51.92 60.96 74.91
R11 45.04 48.89 52.16 58.07 74.92
R12 45.33 48.83 51.72 59.46 77.44
Rt 45.19 48.76 53.05 59.78 76.31
SD 0.2630 0.3605 1.2933 1.0433 0.8616
RSD 0.5820 0.7395 2.4380 1.7452 1.1291
Sum 283.088

Waktu disolusi (Menit)

ATOFAR 10 15 30 45 60
R1 45.11 47.94 52.24 59.48 76.83
R2 45.47 49.42 53.37 60.86 76.44
R3 45.66 49.14 54.17 60.80 76.42
R4 45.24 48.82 52.04 59.80 77.18
R5 44.95 48.83 52.25 61.17 76.69
R6 45.53 48.76 54.62 61.24 76.78
R7 44.96 47.94 54.83 61.49 77.64
R8 44.99 49.42 54.87 59.18 77.83
R9 45.46 49.14 51.83 57.85 77.26
R10 45.08 48.82 51.82 61.13 75.30
R11 44.80 48.83 52.08 57.86 75.32
R12 45.00 48.76 51.65 59.36 77.96
Rt 45.19 48.82 52.98 60.02 76.80
SD 0.2790 0.4753 1.2955 1.2921 0.8647
RSD 0.6174 0.9735 2.4453 2.1529 1.1258
Sum 283.877

Perhitungan nilai f1 dan f2

The difference factor (f1) = 1,551 Tolerance : 0 - 15
The similarity factor (f2) = 84,234 Tolerance : 50 - 100
Dari hasil yang didapat nilai f1 dan f2 memenuhi syarat

Keterangan :
f1 : Difference factor
f2 : Similarity factor
R : Dissolution value
Rt : Dissolution value of the reference batch at time t
Tt : Dissolution value of the test batch at time t.
 latian ngitung F2
Kuard [R-T]^2 ([R-T]^2)/n 1 + [([R-T]^akar 1 + [([R-T]^2)/n]
0.000 0.309851993 0.0619704 1.0619704 1.0305195
0.004
0.005
0.056
0.245
Sum 0.310 100 / akar 1 + [([R-T]^2)/n] log (100 / a 50 log (100 / akar 1 + [([R-T]^2)/n])
1 +1/N 1.077 97.0384373542137 1.9869438 99.34719
Kuad 96.338
Log 1.984

f2 99.190
latian ngitung F1
[R-T] [R]
0.869250000000008 283.088

F1 0.3070596
F2 99.34719
[R-T]^2)/n])
 MEDIA DISOLUSI MEDIA KHUSUS MEDIA KHUSUS
AQUA pH 5,66 DAPAR HCl pH 1,2 DAPAR ASETAT pH 4,5

MEDIA KHUSUS MEDIA KHUSUS MEDIA KHUSUS

DAPAR ASETAT pH 4,5 DAPAR FOSFAT pH 6,8 DAPAR ASETAT pH 4,5

MEDIA KHUSUS MEDIA KHUSUS

DAPAR FOSFAT pH 6,8 DAPAR FOSFAT pH 6,8
 MEDIA KHUSUS
DAPAR FOSFAT pH 6,8