Uji Disolusi Kaplet Asam Mefenamat Produksi PT. Mutiara Mukti Farma (Mutifa) Medan
Mefenamic acid caplets Dissolution Test Produced By PT Mutiara Mukti
Farma (MUTIFA) Medan
ABSTRACT
Mefenamicacidincludepain medicationthat is classifiedasNSAIDs (Non
Steroidal Anti-inflammatory Drugs). Thedrugsused to treatvarioustypesof pain,
but moreoftenprescribed tocope withtoothache, andpainby inhibitingthe synthesis
of
prostaglandin
from
part
of
body
by
inhibitingthe
enzymecyclooxygenasesohasanalgesic, anti-inflammatoryandantipyretic effect.
Purpose of this test is to determine whether mefenamic acid caplets
manufactured by PT Mutiara Mukti Farma (MUTIFA) Field meets dissolution test
requirements as determined by the IV edition of the pharmacopoeia.
Dissolution test against 6 caplets mefenamic acid 500 mg was performed
with a type 2 (paddle method) in medium containing 40 ml of ethanol added to
800 ml of phosphate buffer, with temperature 37 ± 0,5°C and with the pace and
speed of 75 rpm for 45 minutes. soluble substance, where of are set by ultraviolet
spectrophotometric method. dissolution test results for the 6 caplets made
mefenamic acid derived solute levels are: 98.88%, 100.69%, 99.46%, 99.82%,
101.63%, 100.31%. The levels in accordance with the limits set out in the fourth
edition of the pharmacopoeia Indonesia which amount to 6 caplets are tested to
meet the acceptance criteria dissolution test results that none of the levels that are
less than the provisions, namely of (Q + 5%) so (60% + 5% = 65%).
Keyword:Mefenamic acid, NSAIDs, spectrophotometric, dissolution test.
Universitas Sumatera Utara
Uji Disolusi Kaplet Asam Mefenamat Produksi PT Mutiara Mukti Farma
(MUTIFA) Medan
ABSTRAK
Asam mefenamat termasuk obat pereda nyeri yang digolongkan sebagai
NSAIDs (Non SteroidalAnti-inflammatory Drugs). Obat ini digunakan untuk
mengatasi berbagai jenis rasa nyeri namun lebih sering diresepkan untuk
mengatasi sakit gigi, nyeri dengan cara menghambat sintesa prostaglandin dalam
jaringan tubuh dengan menghambat enzim siklooksigenase sehingga mempunyai
efek analgesik, anti-inflamasi dan antipiretik.
Tujuan pengujian ini adalah untuk mengetahui apakah kaplet asam
mefenamat yang diproduksi oleh PT Mutiara Mukti Farma (MUTIFA) Medan
memenuhi persyaratan uji disolusi sesuai dengan yang ditetapkan oleh Farmakope
Edisi IV.
Uji disolusi terhadap 6 buah kaplet asam mefenamat 500 mg dilakukan
dengan alattipe2 (metode dayung) pada media yang berisi 40 ml etanol ditambah
buffer fosfat sampai 800 ml, suhu 37 ± 0,5ºCdengan laju kecepatan 75 rpm dan
selama 45 menit. Zat yang larut, ditetapkan kadarnya dengan metode
spektrofotometri ultraviolet. Hasil uji disolusi terhadap 6 buah kaplet asam
mefenamatyang dilakukan diperoleh kadar zat terlarut yaitu: 98,88%, 100,69%,
99,46%, 99,82%, 101,63%, 100,31%. Kadar tersebut sesuai dengan batas yang
ditetapkan dalam Farmakope Indonesia Edisi IV dimana jumlah ke 6 kaplet yang
diuji memenuhi kriteria penerimaan hasil uji disolusiyaitu tidak satupun kadar
yang diperoleh kurang dari ketentuan, yakni dari (Q + 5%) yaitu (60% + 5% =
65%).
Kata kunci:Asam mefenamat, NSAIDs, spektrofotometri, uji disolusi.
Universitas Sumatera Utara
Farma (MUTIFA) Medan
ABSTRACT
Mefenamicacidincludepain medicationthat is classifiedasNSAIDs (Non
Steroidal Anti-inflammatory Drugs). Thedrugsused to treatvarioustypesof pain,
but moreoftenprescribed tocope withtoothache, andpainby inhibitingthe synthesis
of
prostaglandin
from
part
of
body
by
inhibitingthe
enzymecyclooxygenasesohasanalgesic, anti-inflammatoryandantipyretic effect.
Purpose of this test is to determine whether mefenamic acid caplets
manufactured by PT Mutiara Mukti Farma (MUTIFA) Field meets dissolution test
requirements as determined by the IV edition of the pharmacopoeia.
Dissolution test against 6 caplets mefenamic acid 500 mg was performed
with a type 2 (paddle method) in medium containing 40 ml of ethanol added to
800 ml of phosphate buffer, with temperature 37 ± 0,5°C and with the pace and
speed of 75 rpm for 45 minutes. soluble substance, where of are set by ultraviolet
spectrophotometric method. dissolution test results for the 6 caplets made
mefenamic acid derived solute levels are: 98.88%, 100.69%, 99.46%, 99.82%,
101.63%, 100.31%. The levels in accordance with the limits set out in the fourth
edition of the pharmacopoeia Indonesia which amount to 6 caplets are tested to
meet the acceptance criteria dissolution test results that none of the levels that are
less than the provisions, namely of (Q + 5%) so (60% + 5% = 65%).
Keyword:Mefenamic acid, NSAIDs, spectrophotometric, dissolution test.
Universitas Sumatera Utara
Uji Disolusi Kaplet Asam Mefenamat Produksi PT Mutiara Mukti Farma
(MUTIFA) Medan
ABSTRAK
Asam mefenamat termasuk obat pereda nyeri yang digolongkan sebagai
NSAIDs (Non SteroidalAnti-inflammatory Drugs). Obat ini digunakan untuk
mengatasi berbagai jenis rasa nyeri namun lebih sering diresepkan untuk
mengatasi sakit gigi, nyeri dengan cara menghambat sintesa prostaglandin dalam
jaringan tubuh dengan menghambat enzim siklooksigenase sehingga mempunyai
efek analgesik, anti-inflamasi dan antipiretik.
Tujuan pengujian ini adalah untuk mengetahui apakah kaplet asam
mefenamat yang diproduksi oleh PT Mutiara Mukti Farma (MUTIFA) Medan
memenuhi persyaratan uji disolusi sesuai dengan yang ditetapkan oleh Farmakope
Edisi IV.
Uji disolusi terhadap 6 buah kaplet asam mefenamat 500 mg dilakukan
dengan alattipe2 (metode dayung) pada media yang berisi 40 ml etanol ditambah
buffer fosfat sampai 800 ml, suhu 37 ± 0,5ºCdengan laju kecepatan 75 rpm dan
selama 45 menit. Zat yang larut, ditetapkan kadarnya dengan metode
spektrofotometri ultraviolet. Hasil uji disolusi terhadap 6 buah kaplet asam
mefenamatyang dilakukan diperoleh kadar zat terlarut yaitu: 98,88%, 100,69%,
99,46%, 99,82%, 101,63%, 100,31%. Kadar tersebut sesuai dengan batas yang
ditetapkan dalam Farmakope Indonesia Edisi IV dimana jumlah ke 6 kaplet yang
diuji memenuhi kriteria penerimaan hasil uji disolusiyaitu tidak satupun kadar
yang diperoleh kurang dari ketentuan, yakni dari (Q + 5%) yaitu (60% + 5% =
65%).
Kata kunci:Asam mefenamat, NSAIDs, spektrofotometri, uji disolusi.
Universitas Sumatera Utara