Shelf Life Determination of Aspirin (temporary title)

Rojo, A.B.1, Romualdez, A.L.1, Sado, F.A.1, Sagum, I.M.1, San Juan, N.C.1, Sandoval, A.B.1
1
University of Santo Tomas, Faculty of Pharmacy

Abstract
Introduction
The shelf life of a drug product
is the time that the average drug
characteristic
remains
within
an
approved
specification
after
the
manufacture
[1].
Manufacturers
quality assurance criteria typically
require that a product must recover at
least 90% of the initial value
throughout its life [2]. Shelf life is the
time required for 10% of the drug to
degrade and 90% remain contact.
The difference between shelf
life and expiration date is that the
former generally relates to a drug's
quality over a specified period of time,
whereas the latter relates to both
quality and safety of a medication at a
specific point in time [3].
Reaction kinetics is the study of
rate of chemical change or rate of
reaction and the way in which this rate
is
influenced
by
conditions
of
concentration
of
reactants
and
products, solvent, ionic strength and
temperature. The other factors that
could affect the degradation of
chemical
products
are
pressure,
catalyst and moisture [4][5].
Methodology

Stock
Soln
Solution
A
Solution
B
Solution
C
Solution
D
Solution
E

0.20 mg/ml
0.08 mg/ml

1.263

0.04 mg/ml

0.735

0.032
mg/ml
0.016
mg/ml
0.013
mg/ml

0.569

a=
0.23211
b=
12.7262

0.651
0.746

20 mg SA
=0.20 mg/ml
100 ml H 2 O
Figure 1. Computation of stock solution

C1 V 1=C 2 V 2
mg
( 20 ml )=C ( 50 ml )(0.08
( 20 ml )=C ( 100 ml )
(0.20 mg
)
ml
ml )
2

A C2=0.08 mg/ml

DC 2=0.016 mg/ml

mg
( 20 ml )=C ( 100 ml(0.32
)
( 20 ml )=C (50 ml )
(0.20 mg
)
ml
ml )
2

B C 2=0.04 mg/ml

E C2=0.013 mg/ml

( 20 ml )=C ( 50 ml )
(0.08 mg
ml )
2

C C 2=0.032 mg/ml

Results and Discussion

Table 1. Concentration and absorbance of
solutions
Std. Soln Concentrat Absorban
B Value
ion
ce

Figure 2. Computation of solutions A to E

40 mg ASA
=0.08 mg/ml
500 ml H 2 O

Figure 3. Computation of concentration of

Aspirin solution
Table 2.
Tim
e,
min.
15
30
45
60
90

Absorban
ce
1.048
1.051
1.071
1.082
1.106

50C
Conc. of
Salicylic
acid
0.0641
0.0643
0.0659
0.0668
0.0687

Conc. of
Aspirin
0.0159
0.0157
0.0141
0.0132
0.0113

Log of
conc. Of
aspirin
-1.7986
-1.8041
-1.8508
-1.8794
-1.9469

Conclusion
The higher the concentration,
the higher the absorbance. The higher
the temperature, the faster rate of
reaction. (notes only)
References
[1] Shao,J., Chao,S.(2001).Drug Shelf
Life Estimation. University of
Wisconsin and StatPlus,Inc. Retrieved
from
http://www3.stat.sinica.edu.tw/statistic
a/oldpdf/A11n39.pdf on September
27, 2014

[2] Anderson, g., Scott,M.(1991).

Determination of Product Shelf Life
and Activation Energy For Five Drugs
of Abuse. Retrieved from
http://www.clinchem.org/content/37/3/
398.full.pdf on September 27, 2014
[3] Hulisz,D.(2013). Pharmacy and
Medications. Case Western Reserve
University. Retrieved from
http://www.netwellness.org/healthtopic
s/pharmacy/medshelflife.cfm on
September 27,2014
[4] Barakat,N.(n/a). Principles and
Kinetics of Drug Stability. Retrieved
from
http://www.pua.edu.eg/PUASite/upload
s/file/Pharmacy/Courses/fall
%202013/PHR%20416/Lecture
%201cont.pdf on September 27,2014
[5] Adebayo, A.S.(n/a). Reaction
Kinectics. Retrieved from
pharmstudentstt.weebly.com on
September 27,2014