01 KT 02 KT

Formula / Tablet
/200 Tablet % /200 Tablet
Nebivolol hcl 5.45 Mg 1.09 G 2.32 1.09 G
Lactose 200 140.25 Mg 28.05 G 59.68 28.52 G
MCC PH 101 70.5 Mg 14.1 G 30 14.1 G
CORN STARCH
croscarmelose sodium 9.4 Mg 1.88 G 4 1.41 G
Kollidon CL
Sodium starch glycollate
HPC LM
Povidone K 30 4.7 Mg 0.94 G 2 0.94 G
tween 80 2.35 Mg 0.47 G 1 0.47 G
Meglumin
SLS
Mg Stearat 1.18 Mg 0.24 G 0.5 0.24 G
aerosil 200 1.18 Mg 0.24 G 0.5 0.24 G
Alkohol 96%
Purified water Mg G G
Total 235 Mg 47 G 100 47 G

note : DT croscarmelose sodium 1 % di note : tablet croscarmelose sodium 1 % di

terlalu cepat, fase gripis saat fase
15 - 55 detik dalam dan 2 % di fase luar friab dalam dan 2 % di fase luar

Inovator : 2,19 menit

hasil Fisik 01 KT 02 KT
LOD (1,5- 2,5) 1.61 1.25
Bobot : 235 (224-246 mg) 230 - 239 230 - 239
Diameter : 9 mm 9,02 - 9,06 9,03 - 9,06
tebal: 3,57 - 3,65 3,57 - 3,62
Keras : 6 Kp ( 5-10 KP) 4,25 - 7,75 4,13 - 6,82
Kerapuhan : < 0,5% 0.02 0.06
waktu hancur : TLD 15 menit 0,15 - 0,55 0.12 - 0.38
F1
F2
 02 KT 03 KT 04 AU 05 AU
% /80 Tablet % 150 Tablet % 150 Tablet %
2.32 0.436 G 2.32 0.818 G 2.32 0.818 G 2.32
60.68 11.41 G 60.68 20.685 G 58.68 19.98 G 56.68
30 6.204 G 33 11.633 G 33 11.633 G 33

0.705 G 2 1.41 G 4

2 0.376 G 2 0.705 G 2 0.705 G 2

1 0.188 G 1 0.353 G 1 0.353 G 1

0.5 0.094 G 0.5 0.176 G 0.5 0.176 G 0.5

0.5 0.094 G 0.5 0.176 G 0.5 0.176 G 0.5

0 G 0 G 0 G
100 18.8 G 100 35.2497 G 100 35.25 G 100

croscarmelose sodium 1 % di
fase
dalam dan 2 % di fase luar

02 KT 03 KT 04 AU 05 AU
1.25 1.7 1.77
230 - 239 230-236 230-235
9,03 - 9,06 9 mm 9 mm
3,57 - 3,62 3.5 3.4
4,13 - 6,82 4,38 - 5,19 6,5 - 7,44
0.06
0.12 - 0.38 DT : > 30 Menit 0.39 - 1.04 1.35 - 2.30
19.007 24.176
49.096 42.133
 06 AU 07 AU 07 AU upscale 08 EU
150 Tablet % 150 Tablet % 4300 Tablet % 4000 Tablet
0.818 G 2.32 0.818 G 2.32 23.435 G 2.32 21.8
20.685 G 58.68 20.332 G 57.68 582.865 G 57.68 546.892
11.633 G 33 11.633 G 33 333.465 G 33 310.2

0.705 G 2 0.705 G 2 20.21 G 2 18.8

0.705 G 2
1.058 G 3 30.315 G 3 28.2
0.353 G 1 0.353 G 1 10.105 G 1 4.7

0.176 G 0.5 0.176 G 0.5 5.074 G 0.5 4.7

0.176 G 0.5 0.176 G 0.5 5.074 G 0.5 4.7
20 ml
0 G 0.2838 G 310
35.2497 G 100 35.2497 G 100 1010.827 G 100 939.992

06 AU 07 AU 07 AU upscale 08 EU
2.2 2.27 2.04 2.24
231-239 234-239 234-242 230-238
9,03 - 9,05 9,04 - 9,09 9,07 - 9,08 9,07 - 9,08
3,42 - 3, 49 3,40 - 3, 47 2,86 - 2,91 2,86 - 2,91
4,82 - 6,44 7,44 - 7,82 7,02 - 8,58 6,77 - 9,21

1.23 - 3.04 1.15 - 2.06 2.30 - 3.55 3.00 - 4.15

9.930 4.202 8.630 10.03
54.560 58.276 52.203 50.36
 08 EU 09 EU 09 EU UPSCALE 10 GU
4000 Tablet % 10000 Tablet % 10000 Tablet % 850 Tablet
G 2.32 54.7 G 2.32 54.5 G 2.32 4.6325 G
G 57.68 1355.5 G 58.18 1355.5 G 58.18 114.206 G
G 33 775.5 G 33 775.5 G 33 65.9175 G

47 G 2 47 G 2 3.995 G
G 2

G 3 70.5 G 3 70.5 G 3 5.9925 G

G 0.5 11.8 G 0.5 23.5 G 0.5 1.003 G

1.9975 G
G 0.5 11.8 G 0.5 11.8 G 0.5 1.003 G
G 0.5 11.8 G 0.5 11.8 G 0.5 1.003 G

G 0.775 l 775 ml 0.065875 ml

G 100 2338.4 G 100 2350.1 G 100 199.75 G

08 EU 09 EU 09 EU UPSCALE 10 GU
2.24 2.45 1.69 1.68
230-238 220-240 232 - 237 229-248
9,07 - 9,08 9,06 - 9,11 9,02 -9,09 9,07 - 9,09
2,86 - 2,91 2,87 - 2,91 2,82 - 2,91 3,46 - 3,58
6,77 - 9,21 5,92 - 8,83 5,95 - 8,46 9,5 - 12,9
0.44 0.06
3.00 - 4.15 2.15 - 4.05 0.34 - 0.56 9.15 - 11.09
10.03 9.69 11.428 28.39
50.36 51.126 49.066 32.022
 10 GU 11 GU 12 GU 13 GU
% 850 Tablet % 850 Tablet % 850 Tablet %
2.32 4.6325 G 2.32 4.6325 G 2.32 4.6342 G 2.32
57.17 112.2085 G 56.17 110.211 G 55.17 115.8151 G 57.98
33.00 65.9175 G 33.00 65.9175 G 33.00 65.9175 G 33

2.00 3.995 g 2.00 5.9925 G 3.00

3.995 G 2

3.00 5.9925 G 3.00 5.9925 G 3.00 5.9925 G 3

0.50 1.003 G 0.50 1.003 G 0.50 1.39825 G 0.7
3.995 g 2 3.995 G 2.00
1.00
0.50 1.003 G 0.50 1.18 G 0.50 0.99875 G 0.5
0.50 1.003 G 0.50 1.18 G 0.50 0.99875 G 0.5

0.065875 ml 0.065875 ml 0.065875 ml

199.75 G 199.75 G 199.75 G

10 GU 11 GU 12 GU 13 GU
1.68 1.58 1.96 1.86
229-248 229 - 249 227,2 - 240,3 233,6 - 238,8
9,07 - 9,09 9,05 - 9,08 9,00 - 9,05 9,00 - 9,07
3,46 - 3,58 3,46 - 3,60 3,43 - 3,57 3,30 - 3,53
9,5 - 12,9 7,5 - 14,6 11,9 - 16,7 12,3 - 15,2
0.06 0.13 0.02 0.02
9.15 - 11.09 9.25 - 13.54 9.07 - 10.44 9,57 - 13.45
28.39 11.23 38.6 56.01
32.022 47.18 24.436 17.295
 16 HU 17 HU 15 GU
1000 Tablet % 1000 Tablet % 1000 Tablet %
5.45 G 2.32 5.45 G 2.32 5.45 G 2.32
77.55 G 33 130.84 G 55.68 130.84 G 55.68
133.19 G 56.68 54.05 G 23 77.55 G 33
23.5 G 10

9.4 G 4 11.75 G 5 9.4 G 4

4.7 g 2
4.7 G 2 7.05 G 3
2.35 G 1 2.35 G 1 2.35 G 1

1.18 G 0.5 1.18 G 0.5 1.18 G 0.5

1.18 G 0.5 1.18 G 0.5 1.18 G 0.5
130 g
100 ML 100 ML
235 G 235 G 235 G

16HU 17 HU 15 GU
1.95 2.25 2.44
229-252 232-249 227-243
9 9 9
3,47-3,6 3,31-3,46 3,34-3,57
7,2-11,1 11,5-12,7 7,4-17,1
0.8 0.56 0.04
1'18"-1'25" 1'20-1'38 3,48-5'54
11.497 14.478 10.16
49.79 43.199 52.416
MEDIUM KOMPENDIA HCl 0,01 N ( HPLC )
Nebilet (NB 53489) A-Nebivolol-08 EU
sampel konsentrasi sampel
0 10 15 30 45 60
Nebilet 1 0 54.40 61.78 86.06 100.37 103.62 6/12/2017 Nebivolol 1
Nebilet 2 0 43.11 58.61 82.15 98.43 99.61 Nebivolol 2
Nebilet 3 0 37.90 55.85 81.06 93.20 100.50 Nebivolol 3
Nebilet 4 0 59.05 70.02 88.59 99.54 104.69 6/13/2017 Nebivolol 4
Nebilet 5 0 48.93 65.50 86.87 100.48 103.39 Nebivolol 5
Nebilet 6 0 41.27 62.92 84.45 96.04 105.01 Nebivolol 6
Nebilet 7 0 48.87 58.32 74.67 100.28 101.51 6/14/2017 Nebivolol 7
Nebilet 8 0 54.33 61.28 86.42 108.96 109.40 Nebivolol 8
Nebilet 9 0 48.79 58.50 83.36 109.28 110.30 Nebivolol 9
Nebilet 10 0 52.09 55.51 79.26 88.87 98.21 6/21/2017 Nebivolol 10
Nebilet 11 0 48.99 59.26 86.93 101.26 105.25 Nebivolol 11
Nebilet 12 0 42.78 59.75 85.80 97.60 106.53 Nebivolol 12
rata-rata 0 48.38 60.61 83.80 99.53 104.00 rata-rata
SD 6.18 4.10 3.97 5.72 3.69 SD
RSD 12.77 6.76 4.73 5.75 3.55 RSD
sum 396.31 sum

Nebilet® VS A-Nebivolol-08 AU

min
abs
kuadrat

f1
f2

ph kom
120

kadar (%)
100

80

60

40

20

0
0 10 15
wakt

ph kom
120
kadar (%)

100

80

60
 ph kom
120

kadar (%)
100

80

60

40

20

0
0 10 15
wakt
A-Nebivolol-08 EU A-Nebivolol-09 EU
konsentrasi sampel kons
0 10 15 30 45 60 0
0 57.19 63.54 76.62 84.36 90.55 6/9/2017 Nebivolol 1 0
0 51.24 64.49 76.69 81.17 88.61 Nebivolol 2 0
0 54.27 67.46 83.08 88.16 91.78 Nebivolol 3 0
0 50.99 56.62 63.57 81.97 84.86 6/14/2017 Nebivolol 4 0
0 47.65 57.7600 72.5200 92.4800 91.2300 Nebivolol 5 0
0 47.78 54.9200 72.4500 92.7800 88.9100 Nebivolol 6 0
0 55.21 67.89 87.64 84.05 74.61 7/7/2017 Nebivolol 7 0
0 60.69 74.93 97.48 93 90.85 Nebivolol 8 0
0 58.32 72.56 92.51 91.94 87.91 Nebivolol 9 0
0 50.97 65.14 85.63 82.53 82.23 Nebivolol 10 0
0 53.29 70.59 90.78 87.22 86.64 Nebivolol 11 0
0 50.49 69.83 92.27 87.31 89.13 Nebivolol 12 0
0.00 53.17 65.48 82.60 87.25 87.28 rata-rata 0
4.10 6.39 10.24 4.47 4.86 SD
7.70 9.75 12.39 5.12 5.57 RSD
375.78 sum

Nebilet® VS A-Nebivolol-08 AU Nebilet® VS A-Nebivolol-09 eu

10 15 30 45 60 sum 10
-4.80 -4.87 1.20 12.28 16.73 min 2.19
4.80 4.87 1.20 12.28 16.73 39.87 abs 2.19
23.02 23.71 1.44 150.76 279.75 478.68 kuadrat 4.79

10.06 f1 9.69
50.360 f2 51.126

ph kompendia HCL 0,01 N ph kompendia

120 120
kadar (%)

kadar (%)

100 100

80 80
Nebilet (NB 53489)
60 A-Nebivolol-08 EU 60

40 40

20 20

0 0
0 10 15 30 45 60 0 10 15 30
waktu (menit) waktu (menit)

ph kompendia HCL 0,01 N ph kompendia

120 120
kadar (%)
kadar (%)

100 100

80 80
Nebilet (NB 53489)
60 60
A-Nebivolol-17 HU
 ph kompendia HCL 0,01 N ph kompendia
120 120

kadar (%)
kadar (%)

100 100

80 80
Nebilet (NB 53489)
60 60
A-Nebivolol-17 HU

40 40

20 20

0 0
0 10 15 30 45 60 0 10 15 30
waktu (menit) waktu (menit)
 A-Nebivolol-10 GU
konsentrasi sampel konsentrasi
10 15 30 45 60 0 10
46.47 60.04 76.33 85.43 91.25 6/9/2017 Nebivolol 1 0 27.30
45.57 58.63 77.42 85.83 88.90 Nebivolol 2 0 22.07
46.52 59.00 77.21 85.49 89.62 Nebivolol 3 0 28.81
Nebivolol 4 0
Nebivolol 5 0
Nebivolol 6 0
Nebivolol 7 0
Nebivolol 8 0
Nebivolol 9 0
Nebivolol 10 0
Nebivolol 11 0
Nebivolol 12 0
46.19 59.22 76.99 85.58 89.92 rata-rata 0 26.06
0.5346 0.7310 0.5783 0.2157 1.2040 SD 3.5370
1.1576 1.2344 0.7512 0.2521 1.3389 RSD 13.5724
357.90 sum 283.81

A-Nebivolol-09 eu Nebilet® VS A-Nebivolol-10 Gu

15 30 45 60 sum 10 15
1.38 6.82 13.94 14.08 min 22.32 15.47
1.38 6.82 13.94 14.08 38.41 abs 22.32 15.47
1.92 46.44 194.39 198.20 445.75 kuadrat 498.00 239.37

f1 28.39
f2 32.022

ph kompendia HCL 0,01 N ph kompendia HCL 0,

120
kadar (%)

100

80
Nebilet (NB 53489)
A-Nebivolol-09 EU 60

40

20

0
0 10 15 30 45 60 0 10 15 30 45 60
waktu (menit) waktu (menit)

ph kompendia HCL 0,01 N

Nebilet (NB 53489)

A-Nebivolol-15 GU
 ph kompendia HCL 0,01 N

Nebilet (NB 53489)

A-Nebivolol-15 GU

0 10 15 30 45 60
waktu (menit)
 A-Nebivolol-11 GU
konsentrasi sampel konsentrasi
15 30 45 60 0 10 15 30
47.53 63.51 71.97 78.70 7/13/2017 Nebivolol 1 0 64.59 72.66 88.67
41.49 57.74 70.01 77.85 Nebivolol 2 0 41.38 66.29 86.51
46.39 64.63 74.65 78.79 Nebivolol 3 0 44.61 68.49 81.59
Nebivolol 4 0
Nebivolol 5 0
Nebivolol 6 0
Nebivolol 7 0
Nebivolol 8 0
Nebivolol 9 0
Nebivolol 10 0
Nebivolol 11 0
Nebivolol 12 0
45.14 61.96 72.21 78.45 rata-rata 0 50.19 69.15 85.59
3.2091 3.6973 2.3293 0.5187 SD 12.5720 3.2354 3.6286
7.1098 5.9672 3.2257 0.6612 RSD 25.0472 4.6790 4.2395
sum 376.09

Nebilet® VS A-Nebivolol-11 Gu
30 45 60 sum 10 15 30 45
21.84 27.32 25.56 min -1.82 -8.54 -1.79 20.66
21.84 27.32 25.56 112.50 abs 1.82 8.54 1.79 20.66
477.06 746.15 653.06 2613.64 kuadrat 3.30 72.90 3.20 426.94

f1 11.23
f2 47.180

ph kompendia HCL 0,01 N ph kompendia HCL 0,01 N

120
kadar (%)

100

80
Nebilet (NB 53489) Nebi
A-Nebivolol-10 GU 60 A-Ne

40

20

0
15 30 45 60 0 10 15 30 45 60
waktu (menit) waktu (menit)
 A-Nebivolol-12 GU
entrasi sampel konsentrasi
45 60 0 10 15 30 45 60
90.33 89.86 7/13/2017 Nebivolol 1 0 17.90 24.01 36.26 40.67 43.44
94.38 92.00 Nebivolol 2 0 12.02 24.05 38.34 46.88 51.28
51.88 95.04 Nebivolol 3 0 17.40 27.38 38.98 46.28 50.46
Nebivolol 4 0 40.21 53.65 67.16 69.21 74.15
Nebivolol 5 0 46.99 59.59 68.77 74.96 74.63
Nebivolol 6 0 50.57 60.29 62.86 71.64 69.92
Nebivolol 7 0
Nebivolol 8 0
Nebivolol 9 0
Nebivolol 10 0
Nebivolol 11 0
Nebivolol 12 0
78.86 92.30 rata-rata 0 30.85 41.50 52.06 58.27 60.65
23.4558 2.6030 SD 16.9715 18.0981 15.7025 15.2332 13.7945
29.7424 2.8201 RSD 55.0160 43.6152 30.1613 26.1409 22.7457
sum 243.33

Nebilet® VS A-Nebivolol-12 Gu
60 sum 10 15 30 45 60 sum
11.70 min 17.53 19.11 31.74 41.25 43.36
11.70 44.51 abs 17.53 19.11 31.74 41.25 43.36 152.99
136.93 643.27 kuadrat 307.21 365.32 1007.43 1701.77 1879.66 5261.39

f1 38.60
f2 24.436

HCL 0,01 N ph kompendia HCL 0,01 N

120
kadar (%)

100

80
Nebilet (NB 53489) Nebilet (NB 53489)
A-Nebivolol-11 GU 60 A-Nebivolol-12 GU

40

20

0
45 60 0 10 15 30 45 60
waktu (menit)
 A-Nebivolol-13 GU
sampel konsentrasi
0 10 15 30 45 60
7/20/2017 Nebivolol 1 0 4.36 5.58 9.05 12.72 26.19 7/20/2017
Nebivolol 2 0 2.93 4.15 6.15 13.53 28.35 7/20/2017
Nebivolol 3 0 3.24 3.20 5.78 13.93 30.36 7/20/2017
7/25/2017 Nebivolol 4 0 28.09 41.52 70.42 77.37 74.75 7/25/2017
Nebivolol 5 0 31.93 43.68 72.74 77.08 78.17 7/25/2017
Nebivolol 6 0 21.13 33.07 72.80 76.54 77.33 7/25/2017
Nebivolol 7 0
Nebivolol 8 0
Nebivolol 9 0
Nebivolol 10 0
Nebivolol 11 0
Nebivolol 12 0
rata-rata 0 15.28 21.87 39.49 45.20 52.53
SD 13.3587 19.5713 35.6267 34.8402 26.5938
RSD 87.4259 89.5027 90.2169 77.0886 50.6308
sum 174.36

Nebilet® VS A-Nebivolol-13 Gu
10 15 30 45 60 sum
min 33.10 38.74 44.31 54.33 51.48
abs 33.10 38.74 44.31 54.33 51.48 221.96
kuadrat 1095.33 1500.92 1963.52 2951.84 2649.85 10161.46

f1 56.01
f2 17.295

ph kompendia HCL 0,01 N

120
kadar (%)

100

80
ilet (NB 53489) Nebilet (NB 53489)
ebivolol-12 GU 60 A-Nebivolol-13 GU

40

20

0
0 10 15 30 45 60
waktu (menit)

p
120
kadar (%)

100

80

60
 p
120

kadar (%)
100

80

60

40

20

0
0 10
A-Nebivolol-06 AU A-Nebivolol-07 AU
sampel konsentrasi sampel
0 10 15 30 45 60
Nebivolol 1 0 46.98 64.10 93.91 109.16 112.19 1/11/2017 Nebivolol 1
Nebivolol 2 0 53.96 70.65 95.22 106.30 114.80 1/11/2017 Nebivolol 2
Nebivolol 3 Nebivolol 3
Nebivolol 4 0 Nebivolol 4
Nebivolol 5 0 Nebivolol 5
Nebivolol 6 0 Nebivolol 6
Nebivolol 7 0 Nebivolol 7
Nebivolol 8 0 Nebivolol 8
Nebivolol 9 0 Nebivolol 9
Nebivolol 10 0 Nebivolol 10
Nebivolol 11 0 Nebivolol 11
Nebivolol 12 0 Nebivolol 12
rata-rata 0 50.47 67.38 94.57 107.73 113.50 rata-rata
SD 4.9356 4.6315 0.9263 2.0223 1.8455 SD
RSD 9.7793 6.8743 0.9795 1.8772 1.6261 RSD
sum 433.64 sum

Nebilet® VS A-Nebivolol-06 AU Nebilet® VS A-Nebivolol-07 AU

10 15 30 45 60 sum
min -2.09 -6.77 -10.76 -8.20 -9.49 min
abs 2.09 6.77 10.76 8.20 9.49 37.32 abs
kuadrat 4.39 45.79 115.85 67.31 90.12 323.45 kuadrat

f1 9.93 f1
f2 54.562 f2

ph kompendia HCL 0,01 N ph kom

120 120

kadar (%)
kadar (%)

100 100

80 80
Nebilet (NB 53489)
60 A-Nebivolol-06 AU 60

40 40

20 20

0 0
0 10 15 30 45 60 0 10 15
waktu (menit) waktu

ph kompendia HCL 0,01 N ph kom

120 120
kadar (%)

kadar (%)

100 100

80 80
Nebilet (NB 53489)
60 A-Nebivolol-06 60
 ph kompendia HCL 0,01 N ph kom
120 120

kadar (%)

kadar (%)
100 100

80 80
Nebilet (NB 53489)
60 A-Nebivolol-06 60
UPSCALE
40 40

20 20

0 0
0 10 15 30 45 60 0 10 15
waktu (menit) wakt
A-Nebivolol-07 AU A-Nebivolol-14 GU
konsentrasi sampel konsen
0 10 15 30 45 60 0 10
0 62.65 92.48 104.18 102.41 103.97 Nebivolol 1 0 4.94
0 91.27 98.66 99.02 98.85 98.89 Nebivolol 2 0 3.41
0 Nebivolol 3 0 2.99
0 Nebivolol 4 0
0 Nebivolol 5 0
0 Nebivolol 6 0
0 Nebivolol 7 0
0 Nebivolol 8 0
0 Nebivolol 9 0
0 Nebivolol 10 0
0 Nebivolol 11 0
0 Nebivolol 12 0
0 76.96 95.57 101.60 100.63 101.43 rata-rata 0 3.78
20.2374 4.3699 3.6487 2.5173 3.5921 SD 1.0263
26.2960 4.5725 3.5912 2.5015 3.5415 RSD 27.1509
476.19 sum 176.63

Nebilet® VS A-Nebivolol-07 AU Nebilet® VS A-Nebivolol-14 GU

10 15 30 45 60 sum 10 15
-28.58 -34.96 -17.80 -1.10 2.57 min 49.39 58.94
28.58 34.96 17.80 1.10 2.57 85.02 abs 49.39 58.94
817.05 1222.32 316.78 1.22 6.61 2363.99 kuadrat 2439.78 3474.41

23.76 f1 70.17
33.110 f2 17.429

ph kompendia HCL 0,01 N

120
ph kompendia H
120
kadar (%)

100
kadar (%)

100
80
Nebilet (NB 53489) 80
60 A-Nebivolol-07 AU
60
40
40
20
20
0
0 10 15 30 45 60 0
waktu (menit) 0 10 15 30 45
waktu (menit)

ph kompendia HCL 0,01 N

120
kadar (%)

100

80
Nebilet (NB 53489)
60 A-Nebivolol-16 HU
 ph kompendia HCL 0,01 N
120
kadar (%)

100

80
Nebilet (NB 53489)
60 A-Nebivolol-16 HU

40

20

0
0 10 15 30 45 60
waktu (menit)
 A-Nebivolol-15 GU
konsentrasi sampel konsentrasi
15 30 45 60 0 10 15 30
8.74 40.57 72.66 84.52 Nebivolol 1 0 46.55 67.72 81.56
5.57 15.04 57.82 78.73 Nebivolol 2 0 62.37 76.94 91.26
5.29 15.88 56.76 76.96 Nebivolol 3 0 59.85 75.32 89.20
Nebivolol 4 0 59.13 75.56 89.06
Nebivolol 5 0 49.16 68.19 87.64
Nebivolol 6 0 51.39 70.48 88.67
Nebivolol 7 0 52.24 67.84 84.40
Nebivolol 8 0 53.19 68.89 83.04
Nebivolol 9 0 60.95 69.43 85.31
Nebivolol 10 0
Nebivolol 11 0
Nebivolol 12 0
6.53 23.83 62.41 80.07 rata-rata 0 54.98 71.15 86.68
1.9162 14.5033 8.8897 3.9541 SD 5.6979 3.7141 3.2483
29.3288 60.8617 14.2432 4.9383 RSD 10.3634 5.2200 3.7474
sum 396.09

Nebilet® VS A-Nebivolol-15 GU
30 45 60 sum 10 15 30 45
58.77 24.83 7.21 min -6.61 -10.54 -2.88 6.45
58.77 24.83 7.21 199.15 abs 6.61 10.54 2.88 6.45
3454.30 616.74 51.92 10037.16 kuadrat 43.63 111.17 8.30 41.56

f1 10.16
f2 52.416

ph kompendia HCL 0,01 N

h kompendia HCL 0,01 N 120
kadar (%)

100

80
Nebile
Nebilet (NB 53489) 60 A-Neb
A-Nebivolol-14 GU
40

20

0
0 10 15 30 45 60
15 30 45 60 waktu (menit)
waktu (menit)
 A-Nebivolol-06 UPSCALE
entrasi sampel konsentrasi
45 60 0 10 15 30 45 60
88.99 88.64 Nebivolol 1 0 70.14 76.28 91.79 99.70 102.11
91.16 90.61 8/14/2017 Nebivolol 2 0 63.96 77.77 92.95 98.80 100.92
91.26 90.84 Nebivolol 3 0 62.71 78.92 94.40 100.29 103.48
98.60 91.46 Nebivolol 4 0 65.61 71.93 82.69 90.12 90.15
96.75 86.99 8/16/2017 Nebivolol 5 0 56.06 70.96 82.98 89.47 90.46
95.77 90.78 Nebivolol 6 0 54.63 72.48 84.11 88.16 91.59
89.49 90.80 Nebivolol 7 0
87.70 91.52 8/21/2017 Nebivolol 8 0
97.99 90.13 Nebivolol 9 0
Nebivolol 10 0
Nebivolol 11 0
Nebivolol 12 0
93.08 90.20 rata-rata 0 62.19 74.72 88.15 94.42 96.45
4.1959 1.4725 SD 5.8827 3.3560 5.4445 5.7219 6.3345
4.5079 1.6326 RSD 9.4600 4.4913 6.1762 6.0598 6.5675
sum 415.94

Nebilet® VS A-Nebivolol-06 UPSCALE

60 sum 10 15 30 45 60 sum
13.81 min -13.81 -14.12 -4.35 5.10 7.55
13.81 40.28 abs 13.81 14.12 4.35 5.10 7.55 44.93
190.58 395.24 kuadrat 190.69 199.23 18.94 26.04 57.00 491.90

f1 11.34
f2 50.067

HCL 0,01 N ph kompendia HCL 0,01 N

120
kadar (%)

100

80
Nebilet (NB 53489)
Nebilet (NB 53489)
A-Nebivolol-15 GU 60 A-Nebivolol-06
UPSCALE
40

20

0
45 60 0 10 15 30 45 60
waktu (menit)
 A-Nebivolol-16 HU
sampel konsentrasi
0 10 15 30 45 60
Nebivolol 1 0 59.03 72.71 83.20 89.95 93.21
8/16/2017 Nebivolol 2 0 54.91 72.44 84.70 88.79 89.60
Nebivolol 3 0 59.95 76.47 86.87 90.84 93.53
Nebivolol 4 0
8/21/2017 Nebivolol 5 0
Nebivolol 6 0
Nebivolol 7 0
Nebivolol 8 0
Nebivolol 9 0
Nebivolol 10 0
Nebivolol 11 0
Nebivolol 12 0
rata-rata 0 57.96 73.87 84.92 89.86 92.11
SD 2.6840 2.2528 1.8452 1.0280 2.1825
RSD 4.6305 3.0496 2.1727 1.1440 2.3693
sum 398.73

Nebilet® VS A-Nebivolol-16 HU
10 15 30 45 60 sum
min -9.59 -13.27 -1.12 9.67 11.89
abs 9.59 13.27 1.12 9.67 11.89 45.53
kuadrat 91.92 175.96 1.26 93.43 141.33 503.90

f1 11.49
f2 49.808

ph kompendia HCL 0,01 N p

120 120
kadar (%)

kadar (%)
100 100

80 80
let (NB 53489)
Nebilet (NB 53489)
ebivolol-06 60 A-Nebivolol-16 HU 60
CALE
40 40

20 20

0 0
0 10 15 30 45 60 0 10
waktu (menit)
A-Nebivolol-17 HU A-Nebivolol-21 IU
sampel konsentrasi sampel
0 10 15 30 45 60 0
Nebivolol 1 0 63.71 81.83 92.35 97.39 99.62 Nebivolol 1 0
Nebivolol 2 0 65.28 82.62 95.32 101.45 90.28 Nebivolol 2 0
Nebivolol 3 0 64.37 84.14 97.94 102.33 101.77 Nebivolol 3 0
Nebivolol 4 0 Nebivolol 4 0
Nebivolol 5 0 Nebivolol 5 0
Nebivolol 6 0 Nebivolol 6 0
Nebivolol 7 0 Nebivolol 7 0
Nebivolol 8 0 Nebivolol 8 0
Nebivolol 9 0 Nebivolol 9 0
Nebivolol 10 0 Nebivolol 10 0
Nebivolol 11 0 Nebivolol 11 0
Nebivolol 12 0 Nebivolol 12 0
rata-rata 0 64.45 82.86 95.20 100.39 97.22 rata-rata 0
SD 0.7883 1.1741 2.7968 2.6351 6.1084 SD
RSD 1.2231 1.4169 2.9377 2.6248 6.2829 RSD
sum 440.13 sum

Nebilet® VS A-Nebivolol-17 HU Nebilet® VS A-Nebivolol-21 IU

10 15 30 45 60 sum 10
min -16.08 -22.26 -11.40 -0.86 6.78 min -13.15
abs 16.08 22.26 11.40 0.86 6.78 57.38 abs 13.15
kuadrat 258.49 495.29 130.00 0.75 45.95 930.46 kuadrat 172.81

f1 14.48 f1 11.93
f2 43.199 f2 48.741

ph kompendia HCL 0,01 N ph komp

120 120
kadar (%)
kadar (%)

100 100

80 80
Nebilet (NB 53489)
60 60
A-Nebivolol-17 HU

40 40

20 20

0 0
0 10 15 30 45 60 0 10 15
waktu (menit) waktu (m
 konsentrasi
10 15 30 45 60
66.42 80.97 90.86 94.99 95.53 9/19/2017
59.46 73.40 74.13 85.87 89.31
67.44 75.96 89.01 86.60 94.65
55.20 75.94 89.78 98.86 112.33
58.89 72.76 83.59 88.08 88.10
61.72 79.31 88.91 94.48 95.78

61.52 76.39 86.05 91.48 95.95

4.6947 3.2251 6.3581 5.3410 8.6708
7.6309 4.2219 7.3891 5.8384 9.0368
411.39

A-Nebivolol-21 IU
15 30 45 60 sum
-15.78 -2.25 8.05 8.05
15.78 2.25 8.05 8.05 47.27
249.06 5.04 64.74 64.83 556.48

ph kompendia HCL 0,01 N

Nebilet (NB 53489)

A-Nebivolol-21 IU

10 15 30 45 60
waktu (menit)
MEDIUM ph 1.2
Nebilet (NB 53489) A-Nebivolol-08 EU
sampel konsentrasi sampel
0 10 15 30 45 60
Nebilet 1 0 78.93 100.62 104.98 104.91 103.38 7/30/2017 Nebivolol 1
Nebilet 2 0 72.47 103.47 103.42 100.34 97.66 7/30/2017 Nebivolol 2
Nebilet 3 0 73.19 100.99 106.17 100.94 99.57 7/30/2017 Nebivolol 3
Nebilet 4 0 65.34 104.17 101.64 95.67 100.11 7/30/2017 Nebivolol 4
Nebilet 5 0 68.67 100.30 100.57 101.38 96.73 7/30/2017 Nebivolol 5
Nebilet 6 0 78.58 109.50 106.09 100.76 99.39 7/30/2017 Nebivolol 6
Nebilet 7 0 Nebivolol 7
Nebilet 8 0 Nebivolol 8
Nebilet 9 0 Nebivolol 9
Nebilet 10 0 Nebivolol 10
Nebilet 11 0 Nebivolol 11
Nebilet 12 0 Nebivolol 12
rata-rata 0 72.86 103.18 103.81 100.67 99.47 rata-rata
SD 5.37 3.48 2.35 2.96 2.30 SD
RSD 7.36 3.38 2.26 2.94 2.31 RSD
sum 479.99 sum

Nebilet® VS A-Nebivolol-08 AU

min
abs
kuadrat

f1
f2

ph kom
120

100
kadar (%)

80

60

40

20

0
0 10 15
40

20

0
0 10 15

wakt
A-Nebivolol-08 EU
konsentrasi
0 10 15 30 45 60
0
0
0
0
0
0
0
0
0
0
0
0
0.00 #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
#DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
#DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
#DIV/0!

Nebilet® VS A-Nebivolol-08 AU
10 15 30 45 60 sum
#DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
#DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!
#DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0! #DIV/0!

#DIV/0!
#DIV/0!

ph kompendia HCL 0,01 N

120

100
kadar (%)

80

Nebilet (NB 53489)

60 A-Nebivolol-08 EU

40

20

0
0 10 15 30 45 60
40

20

0
0 10 15 30 45 60

waktu (menit)
PH dapar asetat 4,5
Nebilet (NB 53489)
sampel konsentrasi
0 10 15 30 45 60
Nebilet 1 0 29.89 29.55 47.31 59.64 84.07 7/5/2017
Nebilet 2 0 29.69 42.94 58.46 72.70 83.42 7/5/2017
Nebilet 3 0 29.11 49.74 52.80 66.31 74.47 7/5/2017
Nebilet 4 0 28.52 49.39 56.72 64.56 75.21 7/5/2017
Nebilet 5 0 26.11 45.54 57.63 70.89 81.12 7/5/2017
Nebilet 6 0 30.24 38.88 52.13 71.69 78.46 7/5/2017
Nebilet 7 0 13.96 14.42 29.83 37.49 98.71 7/31/2017
Nebilet 8 0 12.67 18.27 27.16 37.14 98.63 7/31/2017
Nebilet 9 0 7.46 12.17 20.45 28.00 100.33 7/31/2017
Nebilet 10 0 14.64 24.91 38.38 28.40 99.18 7/31/2017
Nebilet 11 0 15.94 23.33 34.25 41.18 101.76 7/31/2017
Nebilet 12 0 19.38 20.08 29.80 39.52 101.28 7/31/2017
rata-rata 0 21.47 30.77 42.08 51.46 89.72
SD 8.29 13.86 13.60 17.65 11.10
RSD 38.64 45.05 32.32 34.30 12.38
sum 235.49
PH dapar asetat 6,8
Nebilet (NB 53489)
sampel konsentrasi
0 10 15 30 45 60
Nebilet 1 0 13.01 15.04 20.88 26.84 32.36 6/16/2017
Nebilet 2 0 12.40 13.42 23.07 30.68 37.96 6/16/2017
Nebilet 3 0 10.25 13.98 23.37 37.70 38.40 6/16/2017
Nebilet 4 0 14.33 14.07 30.89 44.62 48.23 7/17/2017
Nebilet 5 0 10.51 17.02 33.91 46.24 48.39 7/17/2017
Nebilet 6 0 7.74 14.99 23.24 39.98 48.55 7/17/2017
Nebilet 7 0 8.54 15.57 26.98 34.38 49.3 7/21/2017
Nebilet 8 0 11.57 12.87 23.15 37.08 47.11 7/21/2017
Nebilet 9 0 11.43 13.23 23.66 34.68 48.18 7/21/2017
Nebilet 10 0 16.07 23.80 21.12 32.30 41.91 7/21/2017
Nebilet 11 0 14.26 15.98 23.10 35.58 41.53 7/21/2017
Nebilet 12 0 8.28 12.41 25.32 34.48 46.69 7/21/2017
rata-rata 0 11.53 15.20 24.89 36.21 44.05
SD 2.62 3.03 3.91 5.49 5.51
RSD 22.70 19.95 15.71 15.15 12.51
sum 131.89
 NEBIVOLOL 5 MG ( A-Nebivolol-04 AU )
MEDIUM KOMPENDIA HCl 0,01 N ( HPLC )

Nebilet
sampel konsentrasi
0 10 15 30 45 60
Nebilet 1 0 28.49 38.51 52.64 58.75 58.52 1/11/2017
Nebilet 2 0 20.02 34.79 45.18 53.54 61.13
Nebilet 3 0
rata-rata 0 24.26 36.65 48.91 56.15 59.83
SD 5.9892 2.6304 5.2750 3.6840 1.8455
RSD 24.6926 7.1772 10.7851 6.5616 3.0849
sum 225.79

Viagra® VS B-Sildenafil-10 AT
10 15 30 45 60 sum
min -16.44500 -14.60500 -5.37000 1.70500 4.79000
abs 16.44500 14.60500 5.37000 1.70500 4.79000 42.91500
kuadrat 270.43803 213.30603 28.83690 2.90703 22.94410 538.43208

f1 19.007
f2 49.096 Nebivolol 5 mg Ta
70
Kadar (%)
60

50

40

30

20

10

0
0 10 1

Nebilet
A-Nebivolol-04 AU )
A HCl 0,01 N ( HPLC )

Nebivolol ( A-Nebivolol-04 AU )
sampel konsentrasi
0 10 15 30 45 60
Nebivolol 1 0 29.63 46.76 53.27 53.94 55.50 1/11/2017
Nebivolol 2 0 51.77 55.75 55.29 54.94 54.57
Nebivolol 3 0
rata-rata 0 40.70 51.26 54.28 54.44 55.04
SD 15.6553 6.3569 1.4284 0.7071 0.6576
RSD 38.4652 12.4025 2.6315 1.2989 1.1949
sum 255.71

Nebivolol 5 mg Tablet Media HCl 0,01 N

0 10 15 30 45 60

Nebilet A-Nebivolol-04
Waktu (menit) AU
 NEBIVOLOL 5 MG ( A-Nebivolol-05 AU )
MEDIUM KOMPENDIA HCl 0,01 N ( HPLC )

Nebilet
sampel konsentrasi
0 10 15 30 45 60
Nebilet 1 0 28.49 38.51 52.64 58.75 58.52 1/11/2017
Nebilet 2 0 20.02 34.79 45.18 53.54 61.13
Nebilet 3 0
rata-rata 0 24.26 36.65 48.91 56.15 59.83
SD 5.9892 2.6304 5.2750 3.6840 1.8455
RSD 24.6926 7.1772 10.7851 6.5616 3.0849
sum 225.79

Viagra® VS B-Sildenafil-10 AT
10 15 30 45 60 sum
min -24.60500 -18.91000 -7.27500 0.51000 3.28500
abs 24.60500 18.91000 7.27500 0.51000 3.28500 54.58500
kuadrat 605.40603 357.58810 52.92563 0.26010 10.79123 1026.97108

f1 24.176
f2 42.133 Nebivolol 5 mg
70
Kadar (%)
60

50

40

30

20

10

0
0 10

Nebilet
Nebivolol-05 AU )
HCl 0,01 N ( HPLC )

Nebivolol ( A-Nebivolol-05 AU )
sampel konsentrasi
0 10 15 30 45 60
Nebivolol 1 0 51.50 53.41 54.06 53.25 53.91 1/11/2017
Nebivolol 2 0 46.22 57.71 58.31 58.02 59.17
Nebivolol 3 0
rata-rata 0 48.86 55.56 56.19 55.64 56.54
SD 3.7335 3.0406 3.0052 3.3729 3.7194
RSD 7.6413 5.4726 5.3488 6.0625 6.5783
sum 272.78

Nebivolol 5 mg Tablet Media HCl 0,01 N

10 15 30 45 60

Nebilet A-Nebivolol-05
Waktu (menit) AU
 NEBIVOLOL 5 MG ( A-Nebivolol-06 AU )
MEDIUM KOMPENDIA HCl 0,01 N ( HPLC )

Nebilet Nebivolol ( A-Nebivolol-06 AU )

sampel konsentrasi sampel
0 10 15 30 45 60 0
Nebilet 1 0 92.85 99.49 101.29 103.07 101.65 1/11/2017 Nebivolol 1 0
Nebilet 2 0 90.49 97.17 98.48 100.37 100.36 Nebivolol 2 0
Nebilet 3 0 Nebivolol 3 0
rata-rata 0 91.67 98.33 99.89 101.72 101.01 rata-rata 0
SD 1.6688 1.6405 1.9870 1.9092 0.9122 SD
RSD 1.8204 1.6683 1.9893 1.8769 0.9031 RSD
sum 492.61 sum

Viagra® VS B-Sildenafil-10 AT
10 15 30 45 60 sum Nebivolol 5
min 41.20000 30.95500 5.32000 -6.01000 -12.49000
120
abs 41.20000 30.95500 5.32000 6.01000 12.49000 95.97500

Kadar (%)
kuadrat 1697.44000 958.21203 28.30240 36.12010 156.00010 2876.07463 100

f1 19.483 (syarat : 0-15) 80

f2 30.985 (syarat : 50-100)
60

40

20

0
1 2

N
 AU )
HPLC )

A-Nebivolol-06 AU )
konsentrasi
10 15 30 45 60
46.98 64.10 93.91 109.16 112.19 1/11/2017
53.96 70.65 95.22 106.30 114.80

50.47 67.38 94.57 107.73 113.50

4.9356 4.6315 0.9263 2.0223 1.8455
9.7793 6.8743 0.9795 1.8772 1.6261
433.64

Nebivolol 5 mg Tablet Media HCl 0,01 N

1 2 3 4 5 6

Nebilet A-Nebivolol-06
Waktu (menit) AU
 NEBIVOLOL 5 MG ( A-Nebivolol-07 AU )
MEDIUM KOMPENDIA HCl 0,01 N ( HPLC )

Nebilet Nebivolol ( A-Nebivolol-07 AU ) '=> CETA

sampel konsentrasi sampel
0 10 15 30 45 60 0
Nebilet 1 0 92.85 99.49 101.29 103.07 101.65 1/11/2017 Nebivolol 1 0
Nebilet 2 0 90.49 97.17 98.48 100.37 100.36 Nebivolol 2 0
Nebilet 3 0 Nebivolol 3 0
rata-rata 0 91.67 98.33 99.89 101.72 101.01 rata-rata 0
SD 1.6688 1.6405 1.9870 1.9092 0.9122 SD
RSD 1.8204 1.6683 1.9893 1.8769 0.9031 RSD
sum 492.61 sum

Viagra® VS B-Sildenafil-10 AT
10 15 30 45 60 sum Nebivolol 5
min 14.71000 2.76000 -1.71500 1.09000 -0.42500
120
abs 14.71000 2.76000 1.71500 1.09000 0.42500 20.70000

Kadar (%)
kuadrat 216.38410 7.61760 2.94122 1.18810 0.18063 228.31165 100

f1 4.202 (syarat : 0-15) 80

f2 58.276 (syarat : 50-100)
60

40

20

0
1 2

N
 AU )
HPLC )

A-Nebivolol-07 AU ) '=> CETAK DI FH

konsentrasi
10 15 30 45 60
62.65 92.48 104.18 102.41 103.97 1/11/2017
91.27 98.66 99.02 98.85 98.89

76.96 95.57 101.60 100.63 101.43

20.2374 4.3699 3.6487 2.5173 3.5921
26.2960 4.5725 3.5912 2.5015 3.5415
476.19

Nebivolol 5 mg Tablet Media HCl 0,01 N

1 2 3 4 5 6

Nebilet A-Nebivolol-07
Waktu (menit) AU
 MEDIUM KOMPENDIA HCl 0,01 N ( HPLC )

Nebivolol ( A-Nebivolol-08 EU )
sampel konsentrasi
0 10 15 30 45 60
Nebivolol 1 0 25.56 34.15 64.80 75.52 68.82 7/6/2017 (DIULANG KARENA PEAK JELEK)
Nebivolol 2 0 27.64 42.30 57.97 64.39 73.40
Nebivolol 3 0 24.52 38.20 55.66 61.05 67.88
rata-rata 0 25.91 38.22 59.48 66.99 70.03
SD 1.5886 4.0750 4.7526 7.5764 2.9533
RSD 6.1321 10.6630 7.9907 11.3103 4.2169
sum 260.62

Nebilet (53489)
sampel konsentrasi
0 10 15 30 45 60
Nebilet 1 0 83.97 99.99 115.59 112.94 111.48 5/31/2017
Nebilet 2 0 85.07 111.79 123.51 122.02 119.75
Nebilet 3 0 95.86 116.22 123.87 122.61 120.37
rata-rata 0 88.30 109.33 120.99 119.19 117.20
SD 6.5702 8.3893 4.6800 5.4207 4.9634
RSD 7.4408 7.6731 3.8681 4.5479 4.2349
sum 555.01
HPLC )

Nebivolol ( A-Nebivolol-09 EU )
sampel konsentrasi
0 10 15 30 45 60
KARENA PEAK JELEK) Nebivolol 1 0 25.68 53.13 53.81 60.77 63.03 07/06/2017 (DIULANG KARENA PEAK
Nebivolol 2 0 26.75 38.67 52.47 59.64 62.42
Nebivolol 3 0 30.75 42.37 55.37 63.16 67.19
rata-rata 0 27.73 44.72 53.88 61.19 64.21
SD 2.6724 7.5118 1.4514 1.7972 2.5958
RSD 9.6383 16.7961 2.6936 2.9371 4.0425
sum 251.74
17 (DIULANG KARENA PEAK JELEK)