HERLINDA AYUNINGSIH. Method Validation and Levels Determination of
Diclofenac Sodium by HPLC and Its Application to Determination Diclofenac
Sodium Tablets
Spesialite
in Blood Plasma Male Wistar Rats
in Vitro
.
Under guidance of SUSANTI and ASMIYENTI DJALIASRIN DJALIL
The Background:
The use of diclofenac sodium in addressing various problems
for all kinds of pain, migraine and gout. Activities by way of inhibiting the
enzyme cyclo-oxygenase that inhibited prostaglandin formation (Tjay and
R
ahardja, 2007). To ensure safety and minimize the side effects of a drug
necessary to test the drug analysis
in biological fluids (Shargel and Yu, 2005).
T
he Aim of Research:
This research conducted to prove that the high
performance liquid chromatography method is very valid
to define levels of
diclofenac sodium in
tablets
Spesialite
on Wistar rat plasma
in vitro
.
The Method of Research:
Type of research method used is non-experimental
,
inst
ruments such as HPLC
UV
detector
(273
nm
), mobile phase of methanol
:
acetate buffer pH 4.2 by comparison 70:30, the stationary phase chromatography-
oc
tadecyl coloumliquid cylane
and
a flow rate of 0.7
mL
/ min
. Standard materials
used are e merck diclofenac sodium, diclofenac sodium tablets Spesialite and
wist
ar rat blood plasma. Validation of analytical methods include liniearitas,
limit
of
detection, limit of quantitation, precision, accuracy, and conducted
determination
method diklofenakspesialite
sodium in
Wistar
rat plasma in vitro
.
The Result
: Linearity test results obtained with the correlation coefficient r count
or
value = 0.998 (
> r table 0.707
), limit of detection = 0.2 mg / mL, the limit
of
quantitation = 0.6 mg / mL, accuracy
or precision concentration of 4
mg
/ mL
=
0.57
%
coefficient of variation (
≤
2%), precision or accuracy for the addition of
diclofenac sodium. 7 mg / mL average recovery
of
105.4762
%, and determination
of diclofenac sodium tablets 50
mg
Spesialite plasma concentrations obtained
with the 3
series range of levels of 51.002
mg
/ tablet 50.902
mg
/ tablet or
acquired
98.51
%
percent of
- 102
%.
Conclusion:
Based on the above results it can be concluded that the high
pe
rformance liquid chromatography method
is valid
to analyze Spesialite
diclofenac
sodium levels in the
blood plasma of Wistar
rats
in vitro
.