Objective:
To develop and val
idate a new simple, accurate,
precise
and sensitive
high performance liquid chromatographic method (
HPLC
) method for
simultaneous estimation of ubidecarenone and vitamin E acetate in capsule
dosage form as per
international conference on harmonization
(ICH
) guidelines.
Method
s:
The chromatographic separation of drugs were achieved using hypersil
C
8
Result
s:
The optimized method produced sharp peaks with good resolution, minimum tailing factor and satisfactory retention time were f
ound to
be
5.745
min
and 12.565
min
for vitamin E acetate and ubidecarenone respectively.
The method was linear in the range of 60
-180 μg
/ml
for
ubidecarenone and 20
-60
μg
/ml
for vitamin E acetate
with
a correlation coefficient
of 0.99
9 and 0.99
93 respectively.
Mean recoveries observed for
ubidecarenone and vitamin E acetate were 99.85% and 99.73% respectively.
The
percentage relative standard deviation
(% RSD
) of peak area for
system precision, method preci
sion
, and
intermediate precision were
found to be less than 0.37
%.
The
lower degree of %
RSD
obtained has
proved
that the method was precise and robust.
column
(25
0 mm
x 4.
6 mm
, 5μ
) in isocratic elution mode with
a mobile phase of
methano
l: ethano
l: n-hexane
(80:10:10
v/v/v
) at a flow rate of 1 ml
/min with ultra
-violet
(UV
) detection at 210 nm.
Conclusio
n:
A new simple HPLC method was developed and validated as per ICH guidelines for the simultaneous estimation of ubidecarenone and
vitamin E
acetate and the method can be
effectively
applied for the routine analysis of active pharmaceutical ingredient
(API
) and formulations.