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Perbandingan Mutu dan Harga Tablet Asam Mefenamat
Generik dengan Bermerek Dagang yang Beredar di Pasaran.
Universitas
Andalas.
Lampiran 1. Evaluasi Sifat Fisik Tablet
1.
Keseragaman ukuran tablet
Replikasi Tablet floating
metformin HCl 500 mg
Tablet A dari pabrik
X
Tablet B dari pabrik
Y
Tablet C dari pabrik
Z
2.
Keseragaman bobot tablet
Rep
Bobot (mg) Tablet floating
metformin HCl 500 mg Tablet A dari pabrik X Tablet B dari pabrik Y Tablet C dari pabrik Z
20 877,7 834,64 789,93 1016,00 965,50 915,00 869,1 825,71 782,33 1008,8 957,40 906,00
Rata - rata 861,1 1009,6 867,7 1027,92
SD 11,17 5,31 7,74 11,17
Lampiran 2. Penetapan Kadar Metformin HCl 500 mg.
a.
Pembuatan kurva baku
Konsentrasi (mg/ml) Absorbansi
0,01
b.
Perhitungan LOD dan LOQ
Persamaan kurva baku y = 9.216x+0.059
Penimbangan sebenarnya 102,3 mg
c.
Penetapan kadar metformin HCl dalam tablet
i)
Tablet floating metformin HCl 500 mg
Berat penimbangan (mg)
Replikasi Absorbansi Konsentrasi (μg/ml) Kadar
(mg)
% kadar
859,4 1a 0,238 0,97 485,00 96,92
1c 0,222 0,88 440,20 88,05
859,1 2a 0,239 0,97 486,32 97,27
2c 0,234 0,95 472,75 94,56
859,2 3a 0,227 0,91 453,76 90,76
3b 0,226 0,90 451,05 90,22
Rata – Rata 92,93
SD 3,79
CV (%) 4,08
ii)
Tablet A dari pabrik X
Berat penimbangan (mg)
Replikasi Absorbansi Konsentrasi (mg/ml) Kadar
(mg) % kadar
1011,4 1a 0,409 0,95 473,71 94,61
1b 0,403 0,93 465,58 92,98
1011,9 2a 0,407 0,94 471,00 94,07
2b 0,409 0,95 473,71 94,61
1010,2 3a 0,405 0,94 468,29 93,53
3b 0,406 0,94 469,65 93,80
Rata - rata 93,93
SD 0,64
CV (%) 0,68
iii)
Tablet B dari pabrik Y
Berat penimbangan (mg)
Replikasi Absorbansi Konsentrasi (mg/ml) Kadar
(mg) % kadar
869,5 1b 0,423 0,99 492,70 98,34
1c 0,422 0,98 491,35 98,07
870,4 2b 0,453 1,07 533,39 106,46
2c 0,426 0,99 496,77 99,15
870,4 3a 0,425 0,99 495,42 98,88
3b 0,435 1,02 508,98 101,59
Rata - rata 100,41
SD 3,21
iv)
Tablet C dari pabrik Z
Berat penimbangan (mg)
Replikasi Absorbansi Konsentrasi (mg/ml) Kadar
(mg) % kadar
1028 1a 0,418 0,97 485,92 97,18
1b 0,405 0,94 468,29 93,65
1028,3 2b 0,420 0,98 488,63 97,72
2c 0,424 0,99 494,06 98,80
1028 3b 0,425 0,99 495,41 99,08
3c 0,422 0,98 491,35 98,26
Rata - rata 97,45
SD 1,99
CV 2,04
Contoh perhitungan penetapan kadar pada tablet
floating
metformin HCl replikasi
1.
Penimbangan serbuk sebenarnya = 859,4 mg
Perhitungan kadar metformin dalam campuran serbuk (secara penelitian)
Absorbansi yang diperoleh = 0,238, pengenceran 50x
Persamaan kurva baku metformin dalam cairan lambung buatan pH 1,2 :
y = 9,216x + 0,059
0,238 = 9,216x + 0,059
x =
x = 0,97 mg/ml
Kadar metformin HCl dalam 500 ml mengandung :
x= 0,97 mg/ml x 500 ml = 485 mg
Kadar metformin HCl dalam tiap tablet
=
x 500
=
x 500 = 500,04 mg
% kadar metformin per tablet
Lampiran 3. Hasil Uji Disolusi Tablet
Floating
Metformin HCl
1.
Tabulasi hasil serapan metformin HCl pada uji disolusi
Waktu Pengence
ran
Serapan Tablet floating
metformin HCl 500 mg
Tablet A Tabet B Tablet C
Replikasi Replikasi Replikasi Replikasi
1 2 3 1 2 3 1 2 3 1 2 3
5 5 0,176 0,167 0,219 0,178 0,183 0,134 0,181 0,183 0,154 0,172 0,145 0,147
15 5 0,183 0,219 0,265 0,229 0,227 0,242 0,246 0,239 0,238 0,218 0,218 0,207
30 5 0,255 0,297 0,354 0,307 0,314 0,354 0,306 0,308 0,350 0,290 0,278 0,268
45 5 0,323 0,341 0,424 0,364 0,373 0,401 0,360 0,364 0,401 0,360 0,325 0,335
60 5 0,394 0,417 0,479 0,440 0,441 0,426 0,415 0,422 0,413 0,414 0,376 0,436
90 5 0,497 0,501 0,576 0,510 0,524 0,576 0,499 0,496 0,491 0,500 0,488 0,461
120 5 0,584 0,572 0,674 0,594 0,606 0,617 0,553 0,569 0,563 0,575 0,573 0,552
180 5 0,714 0,693 0,749 0,702 0,728 0,742 0,660 0,665 0,661 0,673 0,660 0,658
240 5 0,470 0,477 0,539 0,790 0,814 0,820 0,766 0,761 0,771 0,771 0,740 0,747
300 10 0,540 0,542 0,619 0,519 0,509 0,512 0,466 0,469 0,496 0,466 0,500 0,461
360 10 0,580 0,638 0,685 0,520 0,568 0,566 0,521 0,513 0,549 0,528 0,530 0,512
420 10 0,667 0,662 0,751 0,575 0,576 0,573 0,540 0,564 0,588 0,614 0,569 0,554
480 10 0,688 0,734 0,793 0,588 0,592 0,605 0,573 0,578 0,601 0,618 0,609 0,588
540 10 0,681 0,692 0,732 0,605 0,609 0,612 0,599 0,592 0,612 0,685 0,682 0,658
600 10 0,681 0,701 0,739 0,618 0,669 0,642 0,624 0,645 0,632 0,722 0,724 0,719
2.
Tabulasi hasil persen disolusi Metformin HCl
Waktu
% disolusi Tablet floating metformin
HCl 500 mg
Tablet A Tablet B Tablet C
1 2 3 1 2 3 1 2 3 1 2 3
5 7,515 6,966 10,452 7,695 8,128 4,609 7,848 8,107 6,002 7,280 5,454 5,519
Rata–rata 8,311 6,811 7,319 6,084
SD 1,87 1,92 1,15 0,85
15 7,979 10,627 13,646 11,207 11,159 12,053 12,405 12,035 11,763 10,445 10,564 9,604
Rata–rata 10,751 11,473 12,067 10,204
SD 2,84 0,50 0,32 0,43
30 13,028 16,102 19,752 16,567 17,285 19,793 16,560 16,823 19,531 15,411 14,752 13,819
Rata–rata 16,294 17,882 17,638 14,660
SD 3,37 1,69 1,64 0,65
45 17,703 19,168 24,581 20,564 21,415 23,015 20,259 20,757 23,029 20,259 18,034 18,482
Rata–rata 20,484 21,665 21,348 18,925
SD 3,62 1,24 1,48 0,96
60 22,607 24,482 28,403 25,800 26,155 24,732 24,054 24,804 23,870 23,999 21,604 25,429
Rata–rata 25,164 25,562 24,243 23,677
Rata–rata 45,206 45,596 41,270 41,401
SD 1,62 1,40 0,48 0,50
240 55,825 57,337 65,112 50,041 52,260 51,927 48,357 48,550 48,554 48,718 47,101 46,919
Rata–rata 59,424 51,409 48,4875 47,579
SD 4,98 1,20 0,11 0,81
300 65,535 66,395 76,108 62,626 61,901 61,331 55,160 56,174 59,096 55,174 60,529 54,336
Rata–rata 69,346 61,952 56,810 56,679
SD 5,87 0,65 2,04 2,74
360 70,951 79,921 85,284 62,695 70,036 68,796 62,778 62,391 66,505 63,831 64,729 61,290
Rata–rata 78,718 67,176 63,892 63,283
SD 7,24 3,93 2,27 1,46
420 83,057 83,267 94,376 70,328 71,198 69,734 65,535 69,560 71,817 75,702 70,190 67,085
Rata–rata 86,900 70,420 68,971 70,992
SD 6,48 0,73 3,18 3,56
480 86,008 93,376 100,116 72,073 73,410 74,122 70.009 71.436 73.584 76,339 75,790 71,845
Rata–rata 93,167 73,202 71.676 74,658
SD 7,06 1,04 1.80 2,00
540 106,211 109,369 114,607 74,469 75,902 75,212 73.624 73.410 75.184 85,523 86,053 81,545
Rata–rata 110,063 75,194 74.073 84,374
SD 4,24 0,72 0.97 2,01
600 106,332 110,979 115,918 76,339 84,023 79,282 77.073 80.900 77.902 90,620 91,891 89,961
Rata–rata 111,076 79,881 78.625 90,824
SD 4.,9 3,88 2.01 0,80
Contoh perhitungan persen disolusi metformin HCl 500 mg
Tablet floating replikasi 1
Menit ke-5
Absorbansi 0,176 pengenceran 5x
Bobot rata
–
rata tablet 860,567 mg
Bobot tablet yang didisolusi 862,50 mg
Persamaan regresi y = 14, 406x + 0,067
x =
x = 0,03648 mg/ml
Kadar dalam 1000 ml
x = 0,0364mg/ml x1000 ml = 36,48 mg
Jumlah metformin HCl dalam satu tablet
=
% disolusi metformin HCl
=
=
3.
Tabulasi hasil nilai F
1dan F
2Rep Tablet floating
metformin HCl 500 mg dengan Tablet A
Tablet floating metformin HCl 500 mg dengan Tablet B
Tablet floating metformin HCl 500 mg dengan Tablet C
F1 F2 F1 F2 F1 F2
1 18,25 44,75 21,89 43,97 13,32 54,31
2 18,17 44,83 22,39 41,87 17,03 48,75
3 21,15 37,79 23,69 36,95 24,37 37,62
Rata – rata 19,19 42,45 22,65 40,93 18,24 46,89
Contoh perhitungan nilai f
1, f
2Tablet
floating
metformin HCl dengan Tablet A replikasi 1.
Menit (T(t)) (R(t)) R(t) - T(t) (R(t) - T(t))^2 │R(t) - T(t)│
5 7,515 7,695 0,180 0,032 0,180
15 7,979 11,207 3,227 10,416 3,227
30 13,028 16,567 3,539 12,525 3,539
45 17,703 20,564 2,860 8,182 2,860
60 22,607 25,800 3,192 10,194 3,192
90 29,789 30,675 0,886 0,785 0,886
120 35,780 36,479 0,699 0,489 0,699
180 44,797 43,987 -0,810 0,656 0,810
240 55,825 50,040 -5,784 33,455 5,784
300 65,535 62,626 -2,908 8,461 2,908
360 70,951 62,695 -8,255 68,156 8,255
420 83,057 70,328 -12,729 162,050 12,729
480 86,008 72,073 -13,935 194,184 13,935
540 106,211 74,469 -31,742 1007,557 31,742
600 106,332 76,339 -29,993 899,591 29,993
∑│R(t)
-
T(t)│= 120.745
= 18,25
Perhitungan f
2∑(R(t)
- T(t))^2 = 2416.741
= 12,330
Contoh perhitungan nilai C
Tablet Floating 500 mg
Nilai C Replikasi SD
1 2 3
C60 22,607 24,482 25,164 1,32
C120 35,780 35,333 37,644 1,22
C360 70,951 79,921 78,718 4,86
C600 106,332 110,979 111,076 2,71
Perhitungan C
60tablet
floating
500 mg
C
60=
Contoh perhitungan nilai DE
Tablet
floating
metformin HCl replikasi 1.
Menit % Disolusi Luas AUC
0 – 5 7,52 18,79
5 – 15 7,98 77,48
15 – 30 13,03 157,56
30 – 45 17,70 230,49
45 – 60 22,61 302,33
60 – 90 29,79 785,95
90 – 120 35,78 983,55
120 – 180 44,80 2417,35
180 – 240 55,83 3018,69
240 – 300 65,54 3640,81
300 – 360 70,95 4094,60
360 – 420 83,06 4620,28
420 – 480 86,01 5071,99
480 – 540 106,21 5766,61
540 – 600 106,33 6376,33
Luas AUC menit 0
–
5 =
Luas AUC menit 5
–
15 =
Luas AUC menit 15
–
30 =
Luas AUC menit 30
–
45 =
Luas AUC menit 45
–
60 =
Luas AUC menit 60
–
90 =
Luas AUC menit 90
–
120 =
Luas AUC menit 120
–
180 =
Luas AUC menit 360
–
420 =
Luas AUC menit 420
–
480 =
Luas AUC menit 480
–
540 =
Luas AUC menit 540
–
600 =
∑ Luas AUC =
37562,81
Luas Kurva Segiempat 100 % = 100 x 600 = 60000
DISOLUSI EFISIENSI
Explore
Tablet
Case Processing Summary
Tablet
Cases
Valid Missing Total
N Percent N Percent N Percent
Disolusi_ Efisiensi
Tablet Floating 3 100.0% 0 .0% 3 100.0%
Tablet A 3 100.0% 0 .0% 3 100.0%
Tablet B 3 100.0% 0 .0% 3 100.0%
Tablet C 3 100.0% 0 .0% 3 100.0%
Tests of Normality
Tablet
Kolmogorov-Smirnova Shapiro-Wilk
Statistic df Sig. Statistic df Sig.
Disolusi_ Efisiensi
Tablet Floating .275 3 . .943 3 .541
Tablet A .323 3 . .878 3 .320
Tablet B .175 3 . 1.000 3 .995
Tablet C .354 3 . .821 3 .166
a. Lilliefors Significance Correction
Oneway
Descriptives
Disolusi_Efisiensi
N Mean
Std.
Deviation Std. Error
95% Confidence Interval for Mean
Minimum Maximum Lower
Bound
Upper Bound
Tablet Floating 3 66.4333 4.59709 2.65413 55.0135 77.8531 62.60 71.53
Tablet A 3 55.1933 1.10961 .64063 52.4369 57.9498 53.93 56.01
Tablet B 3 52.7367 1.03500 .59756 50.1656 55.3078 51.70 53.77
Tablet C 3 54.4967 1.50098 .86659 50.7680 58.2253 52.77 55.49
Total 12 57.2150 6.03705 1.74275 53.3792 61.0508 51.70 71.53
Test of Homogeneity of Variances
ANOVA
Disolusi_Efisiensi
Sum of Squares df Mean Square F Sig.
Between Groups 349.529 3 116.510 18.142 .001
Within Groups 51.377 8 6.422
Total 400.906 11
Post Hoc Tests
Multiple Comparisons
Disolusi_Efisiensi LSD
(I) Tablet (J) Tablet
Mean Difference
(I-J) Std. Error Sig.
95% Confidence Interval
Lower Bound Upper Bound
Tablet Floating Tablet A 11.24000* 2.06916 .001 6.4685 16.0115
Tablet B 13.69667* 2.06916 .000 8.9252 18.4682
Tablet C 11.93667* 2.06916 .000 7.1652 16.7082
Tablet A Tablet Floating -11.24000* 2.06916 .001 -16.0115 -6.4685
Tablet B 2.45667 2.06916 .269 -2.3148 7.2282
Tablet C .69667 2.06916 .745 -4.0748 5.4682
Tablet B Tablet Floating -13.69667* 2.06916 .000 -18.4682 -8.9252
Tablet A -2.45667 2.06916 .269 -7.2282 2.3148
Tablet C -1.76000 2.06916 .420 -6.5315 3.0115
Tablet C Tablet Floating -11.93667* 2.06916 .000 -16.7082 -7.1652
Tablet A -.69667 2.06916 .745 -5.4682 4.0748
Tablet B 1.76000 2.06916 .420 -3.0115 6.5315
NILAI C
Explore
Tablet
Case Processing Summary
Tablet
Cases
Valid Missing Total
N Percent N Percent N Percent
Nilai_C Tablet Floating 4 100.0% 0 .0% 4 100.0%
Tablet A 4 100.0% 0 .0% 4 100.0%
Tablet B 4 100.0% 0 .0% 4 100.0%
Tablet C 4 100.0% 0 .0% 4 100.0%
Tests of Normality
Tablet
Kolmogorov-Smirnova Shapiro-Wilk
Statistic df Sig. Statistic df Sig.
Nilai_C Tablet Floating .242 4 . .937 4 .634
Tablet A .225 4 . .932 4 .604
Tablet B .236 4 . .931 4 .600
Tablet C .229 4 . .949 4 .707
a. Lilliefors Significance Correction
Oneway
Descriptives
Nilai_C
N Mean
Std.
Deviation Std. Error
95% Confidence Interval for Mean
Minimum Maximum Lower
Bound
Upper Bound
Tablet Floating 4 61.5825 39.00295 19.50148 -.4799 123.6449 24.08 109.46
Tablet A 4 52.4988 25.29474 12.64737 12.2492 92.7483 25.56 79.88
Tablet B 4 50.2680 25.30952 12.65476 9.9949 90.5411 24.24 78.63
Tablet C 4 53.1162 30.17677 15.08839 5.0983 101.1342 23.68 90.83
Total 16 54.3664 27.60733 6.90183 39.6555 69.0773 23.68 109.46
Test of Homogeneity of Variances
ANOVA
Nilai_C
Sum of Squares df Mean Square F Sig.
Between Groups 295.680 3 98.560 .106 .955
Within Groups 11136.791 12 928.066
Total 11432.471 15
Post Hoc Tests
Multiple Comparisons
Nilai_C LSD
(I) Tablet (J) Tablet
Mean Difference
(I-J) Std. Error Sig.
95% Confidence Interval
Lower Bound Upper Bound
Tablet Floating Tablet A 9.08375 21.54142 .681 -37.8510 56.0185
Tablet B 11.31450 21.54142 .609 -35.6202 58.2492
Tablet C 8.46625 21.54142 .701 -38.4685 55.4010
Tablet A Tablet Floating -9.08375 21.54142 .681 -56.0185 37.8510
Tablet B 2.23075 21.54142 .919 -44.7040 49.1655
Tablet C -.61750 21.54142 .978 -47.5522 46.3172
Tablet B Tablet Floating -11.31450 21.54142 .609 -58.2492 35.6202
Tablet A -2.23075 21.54142 .919 -49.1655 44.7040
Tablet C -2.84825 21.54142 .897 -49.7830 44.0865
Tablet C Tablet Floating -8.46625 21.54142 .701 -55.4010 38.4685
Tablet A .61750 21.54142 .978 -46.3172 47.5522
