Spectrophotometric Methods for Simultaneous estimation of Amitriptyline Hydrochloride and Perphenazine in their Synthetic Mixture
Heta Patel, Megha Shah
Patent Cooperation Treaty (PCT)- A short Communication on International Intellectual Property Filing System
Editorial communication
Spectrophotometric Determination of Dapoxetine in its Pharmaceutical Dosage Form using Quality by Design Approach
Priya Patel, Rajvi Maheda, Rita Prajapati
Spectrophotometric Determination of Chlorpheniramine Maleate in its Pharmaceutical Dosage form using Quality by Design Approach
Rita B. Prajapati, Priya B. Patel, Rajvi Mahida
Volume 9
Issue 6, Dec 2019
ISSN 2277 - 3681
Indexing & Listing
Impact Factor-2.633
(JIF-2015)
Journal of
Pharmaceutical Science and Bioscientific Research
ABSTRACT:
Two simple, accurate, and precise spectrophotometric method have been developed for Amitriptyline
hydrochloride (AMI) and Perphenazine (PER) in their mixture. Amitriptyline hydrochloride has absorbance maxima
at 239 nm and Perphenazine absorbance maxima at 257 nm. Method-A area under curve (AUC) method, which
involves the calculation of integrated value of the Absorbance with respect to wavelength between 230-242nm for
Amitriptyline hydrochloride and 249-259nm for Perphenazine. Method-B First order derivative spectrophotometric
method involves the derivatisation of the Zero absorption spectra for the First absorption spectra. The Zero
crossing point of Amitriptyline hydrochloride and Perphenazine at 254.9nm and 236.6nm was obtained
respectively. Beer’s law is obeyed in the concentration range of 5-25 µg/ml and 2-10 µg/ml for Amitriptyline
hydrochloride and Perphenazine for two methods. The accuracy and precision of the methods were determined
and validated statistically. All the methods sowed good reproducibility and recovery with % RSD less than 1. All
method was found to be rapid, precise and accurate and can be successfully applied for the routine analysis of
Amitriptyline hydrochloride and Perphenazine in their mixture.
KEY WORDS: Amitriptyline hydrochloride, Perphenazine, Area Under curve method, First order derivative
spectroscopic method.
ABSTRACT:
The
current
short
communication
provides
brief
history
of
Patent
cooperation
treaty
along
with
that
it
provides
that
it
is
an
international
treaty
that
allows
patent
protection
for
its
all
member
countries
rather
than
individual
filing
in
individual
countries.
It
is
a
filing
system
rather
than
international
granting
system.
That
provides
time
for
filing,
patentability
assessment,
cost
saving
and
avoids unnecessary time delay. It has harmonize the filing system up to some extent throughout the member countries.
KEY WORDS: International Patent filing, PCT, WIPO
ABSTRACT:
A UV Spectrophotometric method was developed by applying Quality by Design (QbD) approach for the
determination of Dapoxetine its pharmaceutical tablet dosage form. Developed originally as a selective serotonin
reuptake inhibitor. Dapoxetine is used as an antidepressant in this research work, three critical method variables
which are solvent, scanning speed and sampling interval were assessed by applying Design of Experiment (DoE)
approach and was also optimized. The method optimization was performed using a factorial design 33. Two
wavelengths which are 251 nm and 291 nm was selected using water, 0.1 N HCl and Methanol as solvents (later
Methanol was selected as final solvent). Linearity was observed at concentration of 10µg/ml-50µg/ml. The
correlation coefficients for Dapoxetine at both wavelengths are 0.999 and 0.9994 the results of method validation
were in the acceptable range as per ICH guidelines.
KEY WORDS: Dapoxetine, UV spectrophotometry, Quality by design, Validation, Pharmaceutical formulation.
ABSTRACT:
A
UV
Spectrophotometric
method
was
developed
by
applying
Quality
by
Design
(QbD)
approach
for
the
determination
of
Chlorpheniramine
Maleate
in
its
pharmaceutical
dosage
form.
In
this
research
work,
three
critical
method
variables
which
are
solvent,
scanning
speed
and
sampling
interval
were
assessed
by
applying
Design
of
Experiment
(DoE)
approach
and
was
also
optimized.
Two
wavelengths
which
are
261
nm
and
245
nm
was
selected
using
water,
0.1
N
HCl
and
0.1
N
NaOH
as
solvents
(later
HCL
was
selected
as
final
solvent).
Linearity
was
observed
at
concentration
of
10µg/ml
–
50µg/ml.
The
correlation
coefficients
for
Chlorpheniramine
maleate
at
both
wavelengths
is
0.9995
and
0.999.
The
results of method validation were in the acceptable range as per ICH guidelines.
KEY WORDS: Chlorpheniramine Maleate, UV spectrophotometry, Quality by design, Validation parameters, Pharmaceutical formulation.