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.
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%).
