Objective:
The aim of the present work was to develop and validate a
simple UV spectroscopic m
ethod for the determination of d
uloxetine
, which
is
a thiophene
derivative and a selective neurotransmitter reuptake inhibitor for serotonin,
norepinephrine
, and to
lesser
degree dopamine
.
Method
s:
The UV Spectrophotometric
analysis was
performed using Shimadzu UV
-1800 and
Shimadzu UV
-1700 spectrophotometer by using
solvent
system acetonitrile
and water in the ratio of 8:2. Detection was performed at
a wavelength
of
29
0 nm.
Method validation was carried out
according to ICH
Q2R1
guidelines by taking the parameter
s linearity, accuracy, precision, ruggedness,
and robustness
, LOD and LOQ.
Result
s:
The UV Spectrophotometric
method was found linear in the range of 10
-
50 μg
/ml
. The method was rugged and robust with
% relative
standard deviation less than 2.
The extraction recoveries were found to be higher than 99%
in all experimental conditions.
Conclusio
n:
Based upon the performance characteristics, the proposed method was found accurate, precise and rapid and
suitable for the
determination of Duloxetine for routine analysis.