Objective:
To develop and validate a
simple and sensitive RP
-HPLC method for th
e simultaneous determination of
mometasone furoate
(MOM)
and
formoterol fumarate (FOR)
in pharmaceutical dosage forms.
Method
s:
In
RP
-HPLC method
, chromatographic separation was achieved using
a mixture of a solvent system consisting of methanol
–water (pH
3.5) in the ratio of 85:15 % v/v
at a flow rate of
1 ml
/min
and
detection was carried out at 225 nm.
Result
s:
The run time for the simultaneous estimation of drugs for the proposed method was 1
0 min
as drugs eluted at 5.217 min (MOM) and 8.65
0
min
(FOR).
The linearity
was found in the range of 33.33
-299.
97 μg
/ml
and 1
-
9 μg
/ml
for MOM
and FOR
, respectively.
The
values
of limit of
detection and limit of quantification
were 3.634, 0.266 μg
/ml
and 11.014, 0.807 μg
/ml
, which
indicates the sensitivity of the method for the
estimation of MOM and FOR, respectivel
y. The
results of recovery studies for both the drugs were
within the range i.e.
98.8
7-101.48
%
which
indicates the accuracy of the method
. Relative standard deviation
obtained f
rom
repeatability
and
reproducibility studies
were
less than 2
%
indicate
s the
precision of the method.
The
proposed method w
as
validated according to ICH guidelines.
Conclusio
n:
The proposed
RP
-HPLC method was found to
be sensitive
and precise
because of the low LOD
, LOQ and % RSD values (<2). The
proposed
work
does not require ace
tonitrile and ion pairing reagent
as compared
to the reported method
s. Therefore
, method can be used
preferabl
y for routine analysis due to its simplicity and economic
advantages.