Jumlah Media

Jumlah Zat Aktif

Jumlah Cuplikan

Time point ppm Mg terdisolFaktor koreMg terdisol% Terdisolusi

ppm dalam medium

Mg terdisolusi = ppm* media/1000 mL
Faktor koreksi = ppm*sampling (mL)/ 1000 mL
Mg terdisolusi (setelah koreksi) = Mg terdisolusi + faktor koreksi
% Terdisolusi =mg terkoreksi/kandungan*100%
 Data Reference
Timepoint 1 (%disolusi) 2 3 Rata-rata
3 18.700 19.250 18.570 18.840
5 39.700 40.250 39.570 39.840
7 57.900 58.450 57.770 58.040
10 75.890 76.440 75.760 76.030
15 86.390 86.940 86.260 86.530
30 89.390 89.940 89.260 89.530
45 91.890 92.440 91.760 92.030

Data Test
Timepoint 1 2 3 Rata-rata Rt - Tt (Rt - Tt)^2
3 16.700 17.250 16.570 16.840 2.000 4.000
5 37.700 38.250 37.570 37.840 2.000 4.000
7 55.900 56.450 55.770 56.040 2.000 4.000
10 73.890 74.440 73.760 74.030 2.000 4.000
15 84.390 84.940 84.260 84.530 2.000 4.000
30 87.390 87.940 87.260 87.530 2.000 4.000
45 89.890 90.440 89.760 90.030 2.000 4.000
Sigma (Rt - Tt)^2 28.000
1/n 0.333
(1/n) Σ (Rt - Tt)^2 9.333
1 + (1/n) Σ (Rt - Tt)^2 10.333
[1+ (1/n) Σ (Rt - Tt)^2]^-0,5 0.3111
{[1+ (1/n) Σ (Rt - Tt)^2]^-0,5 *100} 31.109
Log {[1+ (1/n) Σ (Rt - Tt)^2]^-0,5 *100} 1.493
50 * Log {[1+ (1/n) Σ (Rt - Tt)^2]^-0,5 *100} 74.644
|Rt - Tt| n |Rt - Tt| n Rt
2.000 6.000 56.520
2.000 6.000 119.520
2.000 6.000 174.120
2.000 6.000 228.090
2.000 6.000 259.590
2.000 6.000 268.590
2.000 6.000 276.090
42.000 1382.520
0.030
3.038
 Data Reference
Time % disolusi Rata-
Point 1 2 3 4 5 6 7 8 9 10 11 12 rata
3 18.700 19.590 20.790 19.020 18.950 19.100 19.250 18.570 19.230 18.790 19.350 18.700 19.170
5 39.700 40.590 41.790 40.020 39.950 40.100 40.250 39.570 40.230 39.790 40.350 39.700 40.170
7 57.900 58.260 58.400 58.220 58.150 58.300 58.450 57.770 58.430 57.990 58.550 57.900 58.193
10 75.890 76.250 76.390 76.210 76.140 76.290 76.440 75.760 76.420 75.980 76.540 75.890 76.183
15 86.390 86.750 86.890 86.710 86.640 86.790 86.940 86.260 86.920 86.480 87.040 86.390 86.683
30 89.390 89.750 89.890 89.710 89.640 89.790 89.940 89.260 89.920 89.480 90.040 89.390 89.683
45 91.890 92.250 92.390 92.210 92.140 92.290 92.440 91.760 92.420 91.980 92.540 91.890 92.183

Data Test
Time % disolusi Rata-
Point 1 2 3 4 5 6 7 8 9 10 11 12 rata Rt - Tt (Rt - Tt)^2 |Rt - Tt|
3 9.700 10.590 11.790 10.020 9.950 10.100 10.250 9.570 10.230 9.700 10.350 9.700 10.163 9.008 81.135 9.008
5 30.700 31.590 32.790 31.020 30.950 31.100 31.250 30.570 31.230 30.790 31.350 30.700 31.170 9.000 81.000 9.000
7 48.900 49.260 49.400 49.220 49.150 49.300 49.450 48.770 49.430 48.990 49.550 48.900 49.193 9.000 81.000 9.000
10 66.890 67.250 67.390 67.210 67.140 67.290 67.440 66.760 67.420 66.980 67.540 66.890 67.183 9.000 81.000 9.000
15 77.390 77.750 77.890 77.710 77.640 77.790 77.940 77.260 77.920 77.480 78.040 77.390 77.683 9.000 81.000 9.000
30 80.390 80.750 80.890 80.710 80.640 80.790 80.940 80.260 80.920 80.480 81.040 80.390 80.683 9.000 81.000 9.000
45 82.890 83.250 83.390 83.210 83.140 83.290 83.440 82.760 83.420 82.980 83.540 82.890 83.183 9.000 81.000 9.000
Σ (Rt - Tt)^2 567.135
1/n 0.083
(1/n) Σ (Rt - Tt)^2 47.261
1 + (1/n) Σ (Rt - Tt)^2 48.261
[1+ (1/n) Σ (Rt - Tt)^2]^-0,5 0.144
{[1+ (1/n) Σ (Rt - Tt)^2]^-0,5 *100} 14.395
Log {[1+ (1/n) Σ (Rt - Tt)^2]^-0,5 *100} 1.158
50 * Log {[1+ (1/n) Σ (Rt - Tt)^2]^-0,5 *100}
57.910
f2
 n |Rt - Tt| n Rt
108.090 230.040
108.000 482.040
108.000 698.320
108.000 914.200
108.000 1040.200
108.000 1076.200
108.000 1106.200
Σ |Rt - Tt| 108.013 Σ n Rt 5547.200
Σ(n|Rt-Tt|) /[Σ nRt] 0.019
Σ(n|Rt-Tt|) /[Σ nRt] *100
1.947
f2
Kadar Standar Parasetamol Perhitungan % terdisolusi (Data Tes
x y Nama Sampel : Erphamol 500 mg
(ppm) (abs) Kurva Baku Standar Paracetamol Faktor Pengenceran : 20x
9 0.8 Timepoint mg
0.85 Absorbansi ppm
8 0.701 0.8 (menit) terdisolusi
7 0.598 0.75 f(x) = 0.0951 x − 0.0601 3 1.494 314.828 283.345
0.7 R² = 0.998751010455732

Absorbansi
6 0.508 0.65 5 1.594 335.858 302.272
5 0.421 0.6 10 1.655 348.687 313.818
0.55
0.5 15 1.674 352.682 317.414
0.45 20 1.693 356.678 321.010
0.4
4 5 6 7 8 9 10 25 1.709 360.043 324.039
Konsentrasi (ppm) 30 1.720 362.356 326.121

Grafik Data Test vs Reference Te

Perhitungan % terdisolusi (Reference Test) 80.000
Nama Sampel : Paracetamol 500 mg
70.000
Faktor Pengenceran : 100x
Timepoint mg faktor mg terdisolusi % terdisolusi 60.000
Absorbansi ppm

% terdisolusi
(menit) terdisolusi koreksi setelah koreksi 50.000
3 0.293 308.729 277.856 1.544 279.399 55.880 40.000
5 0.294 309.780 278.802 1.549 280.351 56.070
30.000
10 0.358 377.078 339.370 1.885 341.255 68.251
15 0.362 381.284 343.156 1.906 345.062 69.012 20.000
20 0.378 398.108 358.297 1.991 360.288 72.058 10.000
3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 3
25 0.380 400.211 360.190 2.001 362.191 72.438
30 0.382 402.314 362.083 2.012 364.095 72.819 Timepoint
an % terdisolusi (Data Test) Data Reference
ampel : Erphamol 500 mg Timepoint % terdisolusi
3 55.880
faktor mg terdisolusi % terdisolusi 5 56.070
koreksi setelah koreksi 10 68.251
1.574 284.919 56.984 15 69.012
1.679 303.952 60.790 20 72.058
1.743 315.561 63.112 25 72.438
1.763 319.178 63.836 30 72.819
1.783 322.794 64.559
1.800 325.839 65.168 Data Test
1.812 327.933 65.587 Timepoint % terdisolusi Rt-Tt (Rt-Tt)^2 |Rt-Tt| n|Rt - Tt|
3 56.984 1.104 1.219 1.104 1.104
5 60.790 4.720 22.278 4.720 4.720
a Test vs Reference Test 10 63.112 5.139 26.409 5.139 5.139
15 63.836 5.176 26.791 5.176 5.176
20 64.559 7.499 56.235 7.499 7.499
25 65.168 7.270 52.853 7.270 7.270
30 65.587 7.232 52.302 7.232 7.232
Σ (Rt - Tt)^2 238.087 Σ n|Rt - Tt| 38.140
Data Reference
Data Test 1/n 1.000 Σ(n|Rt-Tt|) /[Σ nRt] 0.082
(1/n) Σ (Rt - Tt)^2 238.087 Σ(n|Rt-Tt|) /[Σ nRt] *100
8.175
1 + (1/n) Σ (Rt - Tt)^2 239.087 f1
[1+ (1/n) Σ (Rt - Tt)^2]^-0,5 0.065
{[1+ (1/n) Σ (Rt - Tt)^2]^-0,5 *100} 6.454
7 19 21 23 25 27 29 31 33 35
Log {[1+ (1/n) Σ (Rt - Tt)^2]^-0,5 *100} 0.810
point 50 * Log {[1+ (1/n) Σ (Rt - Tt)^2]^-0,5 *100}
40.491
f2
 nRt
55.880
56.070
68.251
69.012
72.058
72.438
72.819
Σ nRt 466.528
 Kadar (mcg/mL)
Waktu (jam) AUC SO Ln SO AUC IV Ln IV
Oral Iv
0 0
Suspensi Oral
LN So
6.136165 0.6875 2.8615 1.8142
0.5 2.75 5.31 2.2475 1.011601 2.4825 1.6696 12 2

1 6.24 4.62 3.6850 1.83098 2.1600 1.5304 101.8

1.5 8.5 4.02 4.5775 2.140066 1.8800 1.3913 1.6 f(x) = − 0.268915838920641 x + 2.79
8 R² = 0.999285236299989
2 9.81 3.5 8.6200 2.283402 3.0750 1.2528 1.4
3 7.43 2.65 6.5150 2.005526 2.3300 0.9746 6
1.2
4 5.6 2.01 8.7900 1.722767 3.1700 0.6981 4 1
6 3.19 1.16 5.1000 1.160021 1.8200 0.1484
20.8
8 1.91 0.66 -7.6400 0.647103 -2.6400 -0.4155 0.6
0
0
0.4 1 2 3 4 5 6
AUC (0-8) 40.2225 19.7790
0.2
Slope 3 titik terakhir -0.2689 -0.2784
0
AUC (8-takhingga) = C7.1030122722 2.37069 3.5 4 4.5 Injeksi
5 IV LN 6iv
5.5

7 0.8000
AUC Total = (AUC 0-8) 47.33 22.15
6 0.6000 f(x) = − 0.278412541508162 x +
R² = 0.999945649758282
Fabsolut = AUC SO/AUC IV*D(IV)/D(SO)*100% 85.46472 5 0.4000

4 0.2000

3
0.0000
3.5 4 4.5 5 5.5 6
2
-0.2000
1
-0.4000
0
0
-0.6000 1 2 3 4 5 6
 1. buat grafik oral dan iv ((waktu vs kadar)
2. Cari AUC SO
Suspensi Oral
LN So 3. Cari AUC IV
4. Ln masing-masing utk membuat pers garis linear
pot X = slope (tiga titik terakhir)
= − 0.268915838920641 x + 2.79012528572265 pot sb.Y -intercept
0.999285236299989
5. buat grafik Ln dari tiga titik terakhir
6. dari grafik dapat R dan persamaan masing-masing untuk menentukan
7. menentukan kadar iv dengan antilon (exp) dari Ln IV
8. ubah auc iv (dengan rumus trapesium)

3 4 5 6 7 8 9

4.5 Injeksi
5 IV LN 6iv
5.5 6.5 7 7.5 8 8.5

(x) = − 0.278412541508162 x + 1.81415501012484

R² = 0.999945649758282

4.5 5 5.5 6 6.5 7 7.5 8 8.5

3 4 5 6 7 8 9
ng-masing untuk menentukan nilai IV pada titik waktu 0
xp) dari Ln IV
No sampel auc total kapsul a auc total kapsul std F
1 15 15.8 94.9367
2 22 19 115.7895
3 18 19.3 93.2642
4 18 18.4 97.8261
5 16 17.2 93.0233
6 17 16.5 103.0303
7 18 17.9 100.5587
8 17 17.5 97.1429
rata - rata f 99.4464
standar deviasi ( SD ) 7.4539
standar deviasi rataan (Sf) / ( RSD ) / ( SDR ) 2.6353
tα (dk=7) t0.1 (dk=7) 90% 95% 98%
1.895 2.365 3.499
CLI (+) 104.4404 105.679 108.6675
CLI (-) 94.4525 93.2139 90.2254

ilai CLI dalam rentang80-125%

no sampel hingga 24
untuk cari nilai kepercayaan hitung rata-rata dari F
Hitung standar deviasi dari F
Hitung rataan standar deviasi
te
Waktu Kadar obat (µg/mL)
AUC SO Ln SO AUC IV Ln IV
(jam) SO IV
0 0 6.05 0.8150 2.8399 1.8
0.5 3.26 5.31 2.4400 1.1817 2.4825 1.669592 Grafik antara Kadar Obat p
1 6.5 4.62 4.0000 1.8718 2.2850 1.530395 12
1.5 9.5 4.52 4.8850 2.2513 2.0200 1.508512
2 10.04 3.56 8.5350 2.3066 3.1050 1.269761 10
3 7.03 2.65 5.8150 1.9502 2.3300 0.97456
4 4.6 2.01 7.7900 1.5261 3.1700 0.698135 8

6 3.19 1.16 5.1000 1.1600 1.6200 0.14842

6
8 1.91 0.46 -7.6400 0.6471 -1.8400 -0.776529
4
AUC (0-8) 39.3800 19.8524
Slope 3 titik terakhir -0.2197 -0.2753 2
AUC (8-takhingga) = C(t-8)/a 8.693673 1.670904
0
0 1 2 3 4
AUC Total = (AUC 0-8) + AUC Tak 48.0737 21.5233

Fabsolut = AUC SO/AUC IV*D(IV)/D(SO)*100% 89.3425 Grafik antara Kadar Ob

6
5
4
3
2
1
0
0 1 2 3 4
antara Kadar Obat per Oral vs Waktu Uji Kurva Linearitas antara Kadar Obat per Oral vs Wak
1.8000
1.6000
1.4000 f(x) = − 0.219738265359128 x + 2.42948974627155
R² = 0.990777211568354
1.2000

Ln per Oral
1.0000
0.8000
0.6000
0.4000
0.2000
0.0000
3.5 4 4.5 5 5.5 6 6.5 7 7.5
Waktu Uji
2 3 4 5 6 7 8 9

antara Kadar Obat IV vs Waktu Uji Kurva Linearitas antara Kadar Obat IV vs W
Uji
1.2
1
f(x) = − 0.275305232605153 x + 1.80002746368479
0.8 R² = 0.999998015078105
Ln IV

0.6
0.4

2 3 4 5 6 7 8 9 0.2
0
2.5 3 3.5 4 4.5 5 5.5 6
Waktu Uji
Obat per Oral vs Waktu Uji

8 x + 2.42948974627155

6 6.5 7 7.5 8 8.5

u Uji

adar Obat IV vs Waktu

x + 1.80002746368479

4.5 5 5.5 6 6.5

u Uji
Sukarelaw AUC Total KAUC Total F
1 18.7 15.8 118.3544
2 17.8 19 93.68421
3 19.98 19.3 103.5233
4 15.88 18.4 86.30435
5 17.89 17.2 104.0116
6 19.99 16.5 121.1515
7 14.56 17.9 81.34078
8 10.7 17.5 61.14286
rata - rata f 96.1891
standar deviasi ( SD ) 19.9360
standar deviasi rataan (Sf) / ( RSD 7.0484
tα (dk=7) t0.1 (dk=7) 70% 80% 90%
1.119 1.415 1.895
CLI (+) 104.0763 106.1627 109.5459
CLI (-) 88.30194 86.21561 82.83236

ilai CLI dalam rentang80-125%