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Soal Essay (Waktu 50 menit)

1. Preparasi sampel : 20 tablet amoksisilin ditimbang berat tabletnya, digerus, kemudian diayak dan dianalisis
dengan NIR. Data spektrum NIR dimasukkan kedalam model PLS dan didapat kadar amoksisilin dalam
sampel sebesar 87,8%b/b. Bila berat tablet rata-rata 650,0 mg dan komposisi sampel tiap tablet mengandung
amoksisilin setara amoksisilin trihidrat 500 mg, apakah kadar sampel memenuhi persyaratan farmakope
(90% - 120% dari label klaim). Kesetaraan amoksisilin = 1,15 amoksisilin trihidrat.

2. Komposisi : Tiap 5mL mengandung parasetamol 120mg


Preparasi sample : dipipet 1,0 mL sample ditambah pelarut NaOH 0,01M ad 100,0mL, dikocok ad homogen,
dipipet 1,0mL ditambah NaOH 0,1 M ad 25 mL. Setelah diamati dengan spektrofotometer UV-Vis  257 nm
didapat data sbb:

Identitas Konsentrasi (ppm) Absorbasi


Standar 1 4,09 0,312
Standar 2 6,14 0,472
Standar 3 8,18 0,612
Standar 4 10,08 0,742
Standar 5 12,28 0,984
Sampel ?ppm ?mg 0,768

Hitung kadar bahan aktif dlm sirup Itramol %b/v dan %akurasi?

3. Preparasi sample : ditimbang 20,0 mg sample ditambah pelarut ad 10,0mL, dikocok ad homogen, dipipet
200,0µL ditambah reagen folin dan Lar Na2CO3 ad 1,5mL. Setelah diamati dengan spektrofotometer UV-Vis
 628 nm didapat data kadar fenol 20,0ppm. Berapa kadar fenol dalam mg asam galat ekivalen per gram
sampel (mg AGE/g)
Massa dalam 1mL = 20,0 ppm = 20,0 µg/mL x 1 mL = 20,0 µg
Massa dalam 10,0mL = 20,0 µg x 10,0mL = 20,0 µg x 10.000µL = 2000,0µg = 2,0 mg AGE
100,0µL 100µL
Kadar fenol = 2,0 mg /20,0 mg sampel = 2,0 mg / 0,020gram sampel = 100,0 mg AGE/gram sampel

Massa dalam 1,5mL = 20,0 ppm = 20,0 µg/mL x 1,5 mL = 30,0 µg


Massa dalam 10,0mL = 30,0 µg x 10,0mL = 15,0 µg x 10.000µL = 1500,0µg = 1,5 mg AGE
200,0µL 100µL
Kadar fenol = 1,5 mg /20,0 mg sampel = 2,0 mg / 0,020gram sampel = 75,0 mg AGE/gram sampel

4. Untuk data NIR  yang terbaca pada model adalah konsentrasi 1/10 mg AGE/gram sampel
Kandunan fitokimia  fenol, flavonoid, alkalid, terpenoid, saponin tanin
1. Please read the data below and than answer the question :
 Label claim : each tablet consist of amoxicillin trihydrate equivalent to amoxicillin 500mg
 USP 25 requirement : Amoxicillin tablet contains not less than 90,0% and not more than 120,0% of
the labeled amount of amoxicillin
 Martindale 33th Ed : 1,15 g Amoxicillin trihydrate is approximately equivalent to 1 g of amoxicillin
 Sample preparation : Twenty tablets were weighed and their average weight was 650 mg. The
tablets were mixed and finely powdered. 35 mg of powdered sample was weighed and transferred
into a 100mL volumetric flask, and approximately 50 mL of the solvent was added. The mixture was
ultrasonicated for 5 min and then diluted to 100 mL with the same solvent. The solution was filtered
through a Whatman type-40 filter paper. The solution was observed by spectro UV Vis at 272 nm
 Result data from spectro UV Vis :
Identity Sample weight Concentration Absorbance
Standard solution 1 100 ppm 0.260
Standard solution 2 200 ppm 0.532
Standard solution 3 300 ppm 0.778
Standard solution 4 400 ppm 1.022
Sample X 35,0 mg 0.811
a. calculate the theoritical concentration of amoxicillin in the tablet %w/w ?
b. calculate the observation concentration of amoxicillin in the tablet %w/w ?
c. calculate % recovery of the sample? Does the concentration fulfilled the USP requirement?
 Label claim : each 5,0mL dry syrup consist of amoxicillin trihydrate equivalent to amoxicillin
120mg
Density of the syrup 1,12 g/mL  5,6gram syrup consist of amoxicillin trihydrate equivalent to
amoxicillin 120mg  5,6gram syrup consist of amoxicillin trihydrate 138mg
 USP 25 requirement : Amoxicillin tablet contains not less than 90,0% and not more than 120,0% of
the labeled amount of amoxicillin
 Martindale 33th Ed : 1,15 g Amoxicillin trihydrate is approximately equivalent to 1 g of amoxicillin
 Sample preparation : 1,22 g of syrup sample was weighed and transferred into a 100mL volumetric
flask, and approximately 50 mL of the solvent was added. The mixture was ultrasonicated for 5 min
and then diluted to 100 mL with the same solvent. The solution was filtered through a Whatman type-
40 filter paper. The solution was observed by spectro UV Vis at 272 nm
 Result data from spectro UV Vis :
Identity Sample weight Concentration Absorbance
Standard solution 1 100 ppm 0.260
Standard solution 2 200 ppm 0.532
Standard solution 3 300 ppm 0.778
Standard solution 4 400 ppm 1.022
Sample X
35,0 mg 0.811

d. calculate the theoritical concentration of amoxicillin in the tablet %w/w ?


e. calculate the observation concentration of amoxicillin in the tablet %w/w ?
f. calculate % recovery of the sample? Does the concentration fulfilled the USP requirement?

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