PRAKTEK INDUSTRI

Rancangan Uji Stabilitas Ibuprofen

Kelompok 3
Fepry Harvito, S.Farm.
(1520303247)
Feri Andriyanto , S.Farm.
(1520303248)
Fika Prasetyaningrum , S.Farm. (1520303249)
Finda Farinda , S.Farm. (1520303250)
Fitria Alwi, S.Farm.
(1520303251)

Ibuprofen
(BP: 3128; Martindale: 64; FI V: 541)
Nama Resmi :Ibuprofen
Nama Lain :Ibuprofeeni; Ibuprofn; Ibuprofenas; Ibuprofne;
Ibuprofeno; Ibuprofenum;
Nama Kimia : 2-(4-Isobutylphenyl) propionic acid.
Rumus Mol : C13H8O2; BM = 206,3
Pemerian : serbuk kristal, putih hingga hampir putih, berbu khas lemah
Kelarutan : sangat mudah larut dalam etanol, metanol, aseton dan
kloroform, sukar larut dalam etil asetat, praktis tidak larut air
pH : 2-6
Stabilitas : Stabil, mudah terbakar, kompatibel dengan oksidator kuat
Titik Lebur : 75-78 C
Indikasi : Analgesik, antiinflamasi non steroid
Wadah & Penyimpanan: Simpan di tempat yang sejuk dan kering dalam
wadah
tertutup rapat

Preformulasi drug characterisation

Pengujian menurut WHO

1. General
2. Stress testing
3. Selection of batches
4. Container closure system
5. Spesification
6. Testing Frequency
7. Storage condition
8. Stability commitment
9. Evaluation
10.Statement & labelling
11.In use stability

Parameter pengujian WHO

Kelas penyimpanan menurut WHO

PENGUJIAN DIPERCEPAT
40C 2C/75% RH 5% RH selama
6 bulan

Standard curve preparation

I. A weight of accurately 100 mg of ibuprofen was taken &

dissolved in 100 ml of 0.1 N NaOH solution.( solution A )
II. From the solution A 10 ml was pipette out & diluted to
100 ml in a volumetric flask with 0.1 N NaOH solution
( solution B )
III. From solution B different volumes of 0.1 ml, 0.2 ml, 0.4
ml, 0.6 ml 0.8 ml & 1ml were taken and diluted up to 10
ml with0.1 N NaOH solution.
IV. The absorbance was measured at 223 nm in U V
spectrophotometer against 0.1 N NaOH solution as blank.
4
V. A graph was plotted by taking concentration VS
absorbance.

Accelerated stability studies

About 100mg of ibuprofen was accurately weighed and
transferred the ibuprofen into a 250 ml conical flask.
About 1 or 2 ml alcohol was added to dissolve the ibuprofen
and makeup 100ml with0.1 N NaOH solution.
The conical flask was corked and kept in water bath at 40C
Immediately after placing in water bath, 1ml sample of mixture
was taken which represents zero time samples.
At regular interval of 10, 20,30,40,50 and 60minutes,1 ml of
samples were withdrawn from the container and makeup the
volume to 10 ml with 0.1 N NaOH solution
The absorbance was measured at 223 nm in U V
spectrophotometer against a blank.
A graph was plotted by taking time on x axis and log percent
aspirin undecomposed on y axis.
The same procedure was repeated at 60 c and 70 c
The slopes of these graph were calculated and, Arrhenius plots
were made by plotting logarithm of rate constants against the
reciprocal of absolute temperature.

Perubahan bermakna pada uji dipercepat

TERIMAKASIH
MOHON SARAN DAN BIMBINGANNYA