viii

DAFTAR ISI

HALAMAN JUDUL ........................................................................................ i

HALAMAN PENGESAHAN .......................................................................... ii

SURAT PERNYATAAN................................................................................. iii

PERNYATAAN PERSETUJUAN PUBLIKASI KARYA ILMIAH.............. iv

PRAKATA ....................................................................................................... v

DAFTAR ISI .................................................................................................... viii

DAFTAR SINGKATAN ................................................................................. xi

DAFTAR TABEL ............................................................................................ xii

DAFTAR GAMBAR ....................................................................................... xiv

DAFTAR LAMPIRAN .................................................................................... xv

INTISARI ......................................................................................................... xvi

BAB I PENDAHULUAN ........................................................................... 1

1.1 Latar Belakang ....................................................................... 1

1.2 Rumusan Masalah .................................................................. 3

1.3 Tujuan Penelitian ................................................................... 3

1.3.1 Tujuan Umum ............................................................ 3

1.3.2 Tujuan Khusus ............................................................ 3

1.4 Manfaat Penelitian ................................................................. 3

1.4.1 Manfaat Teoritis ......................................................... 3

1.4.2 Manfaat Praktis .......................................................... 4

BAB II TINJAUAN PUSTAKA .................................................................. 5

2.1 Tinjauan Pustaka .................................................................... 5

2.1.1 Obat Generik Dan Obat Merk Dagang ....................... 5

ix

2.1.2 Siprofloksasin ............................................................. 6

2.1.3 Pemeriksaan Sifat Fisik Tablet ................................... 10

2.1.4 Disolusi ....................................................................... 13

2.1.5 Spektrofotometri Ultraviolet ...................................... 24

2.2 Kerangka Teori....................................................................... 26

2.3 Kerangka Konsep ................................................................... 26

2.4 Hipotesis ................................................................................. 26

BAB III METODE PENELITIAN ................................................................ 27

3.1 Jenis Penelitian dan Rancangan penelitian ............................ 27

3.2 Variabel dan Definisi Operasional ......................................... 27

3.2.1. Variabel ...................................................................... 27

3.2.2. Definisi Operasional ................................................... 27

3.3 Populasi dan Sampel .............................................................. 29

3.3.1. Populasi ...................................................................... 29

3.3.2. Sampel ........................................................................ 29

3.4 Instrumen dan Bahan Penelitian............................................. 29

3.4.1. Instrumen .................................................................... 29

3.4.2. Bahan Penelitian ......................................................... 30

3.5 Cara Penelitian ....................................................................... 30

3.5.1. Pemeriksaan Sifat Fisik Tablet ................................... 30

3.5.2. Penetapan Laju Disolusi Tablet Siprofloksasin 500

mg ............................................................................... 32

3.5.3. Profil Disolusi ............................................................ 33

3.6 Alur Penelitian ....................................................................... 35

3.7 Tempat dan Waktu ................................................................. 35

x

3.7.1. Tempat ........................................................................ 35

3.7.2. Waktu ......................................................................... 35

3.8 Analisa Hasil .......................................................................... 36

BAB IV HASIL DAN PEMBAHASAN ...................................................... 37

4.1. Hasil Penelitian ...................................................................... 37

4.1.1. Uji Sifat Fisik ............................................................. 37

4.1.2. Profil Disolusi ............................................................ 41

4.2. Pembahasan ............................................................................ 45

BAB V KESIMPULAN DAN SARAN ....................................................... 53

5.1. Kesimpulan ............................................................................ 53

5.2. Saran ....................................................................................... 53

DAFTAR PUSTAKA ..................................................................................... 54

LAMPIRAN ..................................................................................................... 58

xi

DAFTAR SINGKATAN

BCS = Biopharmaucuitics Classification System

C = Celsius

CSS = Cairan Cerebro Spinal

CV = Coeffisien Variation

DE = Dissolution Efficiency

DNA = Deoxyribonucleic Acid

FI V = Farmakope Indonesia Edisi V

G = gram

Kgf = Kilo gram force

KHM = Konsentrasi Hambat Minimum

mg = mili gram

ml = mili liter

nm = nanometer

pH = potensial Hidrogen

Q = Jumlah obat yang larut dalam suatu waktu tertentu

RPM = Revolutions Per Minute

SD = Standar Deviasi

USP = United States Pharmacopeial

xii

DAFTAR TABEL

Tabel 2.1. Konsentrasi serum maksimum dan area di bawah kurva dari

Siprofloksasin ............................................................................. 8

Tabel 2.2. Persyaratan keseragaman Bobot Tablet ...................................... 10

Tabel 2.3. Satuan Kekerasan Tablet ............................................................ 11

Tabel 2.4. Penerimaan Syarat Hasil Uji Disolusi ........................................ 23

Tabel 4.1. Hasil Uji Keseragaman Bobot .................................................... 37

Tabel 4.2 Homogenitas Keseragaman Bobot .............................................. 38

Tabel 4.3. Uji T-test Keseragaman Bobot ................................................... 38

Tabel 4.4. Hasil Uji Kekerasan Tablet ......................................................... 38

Tabel 4. 5 Normalitas Kekerasan Tablet ...................................................... 39

Tabel 4. 6 Homogenitas Kekerasan Tablet .................................................. 39

Tabel 4. 7 Uji T-test Kekerasan ................................................................... 39

Tabel 4. 8 Kerapuhan Tablet Siprofloksasin 500 mg .................................. 39

Tabel 4.9. Normalitas Kerapuhan ................................................................ 40

Tabel 4.10. Homogenitas Kerapuhan ............................................................. 40

Tabel 4.11 Uji T-test Kerapuhan .................................................................. 40

Tabel 4. 12 Hasil Uji Disintegrasi .................................................................. 40

Tabel 4.13. Normalitas Disintegrasi .............................................................. 41

Tabel 4.14. Homogenitas Disintegrasi ........................................................... 41

Tabel 4.15. Uji T-test Disintegrasi ................................................................. 41

Tabel 4.16. Nilai Pengukuran Kurva Baku .................................................... 42

Tabel 4.17. Hasil Rata-rata uji Disolusi Menit ke – 30 ................................. 43

Tabel 4. 18 Normalitas Q30 ........................................................................... 43

xiii

Tabel 4. 19 Homogenitas Q30 ....................................................................... 43

Tabel 4. 20 Uji T-test Q30 ............................................................................. 43

Tabel 4. 21 Hasil Rata-rata Uji Dissolution Efficiency (DE) 60 ................... 44

Tabel 4.22. Normalitas Dissolution Eficiency (DE) 60 ................................. 45

Tabel 4.23. Homogenitas Dissolution Eficiency (DE) 60 ............................. 45

Tabel 4.24. Uji T-Test Dissolution Eficiency (DE) 60 .................................. 45

xiv

DAFTAR GAMBAR

Gambar 2. 1. Struktur Kimia Siprofloksasin .......................................................... 7

Gambar 2. 2. Bagan proses disolusi hingga respon klinis sutau zat aktif dari

sediaan tablet / kapsul ..................................................................... 14

Gambar 2. 3. Kerangka Teori ............................................................................... 26

Gambar 2. 4. Kerangka Konsep ........................................................................... 26

Gambar 3. 1. Alur Penelitian ................................................................................ 35

Gambar 4. 1 Profil Spektra Siprofloksasin .......................................................... 42

xv

DAFTAR LAMPIRAN

Lampiran 1. Hasil Data Keseragaman Bobot Tablet Siprofloksasin 500 mg 58

Lampiran 2. Data Hasil Uji Kekerasan Tablet Siprofloksasin 500 mg ......... 61

Lampiran 3 Data Hasil Kerapuhan Tablet Siprofloksasin 500 mg .............. 62

Lampiran 4. Data Hasil Disintegrasi Tablet Siprofloksasin 500 mg ............ 63

Lampiran 5. Pembuatan Media Disolusi Larutan Asam Klorida (HCl) 0,01

N ............................................................................................... 64

Lampiran 6. Data Hasil Uji Disolusi ............................................................ 68

Lampiran 7. Perhitungan DE60 .................................................................... 72

Lampiran 8. Hasil Analisa Data .................................................................... 74

Lampiran 9. Certificate Of Analysis Siprofloksasin Ep ............................... 91

Lampiran 10. Ethical Clearance ..................................................................... 92

Lampiran 11. Dokumentasi Penelitian ............................................................ 93