Analytical Quality by Design for Chiral Pharmaceuticals: A Robust HPLC Method for Upadacitinib Enantiomeric Quantification
Chirality,
Journal Year:
2025,
Volume and Issue:
37(5)
Published: May 1, 2025
ABSTRACT
Ensuring
the
enantiomeric
purity
of
chiral
pharmaceuticals
is
paramount
for
patient
safety
and
therapeutic
efficacy.
Upadacitinib
(UPA),
a
vital
Janus
kinase
1
(JAK‐1)
inhibitor
rheumatoid
arthritis
treatment,
exemplifies
this
need.
This
study
represents
development
robust
HPLC
method,
engineered
using
analytical
quality
by
design
(AQbD),
simultaneous
quantification
UPA
its
impurity
in
pharmaceutical
formulations.
Our
AQbD
approach
systematically
optimized
chromatographic
separation
on
Chiralpak
IG
column
under
isocratic
elution
n‐hexane/ethanol
mixture
(70:30,
v/v)
at
flow
rate
1.8
mL/min,
UV
detection
230
nm,
temperature
40
°C.
Rigorous
validation
accuracy
profiles
confirmed
method
suitability.
Recognizing
growing
imperative
sustainable
practices,
we
further
assessed
environmental
impact
through
comprehensive
greenness
metrics,
while
applicability
sustainability
were
Blue
Applicability
Grade
Index
(BAGI)
Red‐Green‐Blue
12
(RGB12)
algorithms,
respectively.
innovation
empowers
manufacturers
with
reliable
tool
to
guarantee
regulatory
compliance
formulations,
ultimately
contributing
safer
more
effective
therapies.
Language: Английский
Robust analytical method for the enantiomeric separation of lurasidone hydrochloride: Integrating analytical quality by design and green chemistry principles
Sustainable Chemistry and Pharmacy,
Journal Year:
2024,
Volume and Issue:
42, P. 101788 - 101788
Published: Sept. 27, 2024
Language: Английский
RP-HPLC-based simultaneous quantification and stability assessment of doxycycline hyclate and aloe-emodin in lipid nanocarriers
Accreditation and Quality Assurance,
Journal Year:
2025,
Volume and Issue:
unknown
Published: March 17, 2025
Language: Английский
Comparative study of Normal-phase versus reversed-phase HPTLC methods for the concurrent quantification of three antiviral agents against COVID19: Remdesivir, favipiravir and Molnupiravir: trichromatic sustainability assessment
Dina S. El‐Kafrawy,
No information about this author
Amira H. Abo-Gharam
No information about this author
BMC Chemistry,
Journal Year:
2025,
Volume and Issue:
19(1)
Published: March 28, 2025
The
pursuit
of
sustainability
in
analytical
chemistry
is
a
multifaceted,
challenging
and
complex
endeavor.
This
requires
continuous
competitive
attempts
to
achieve
the
sustainable
development
goals
at
every
step
methodology
by
adhering
principles
green,
blue
white
chemistry.
also
involves
assessment
degree
using
latest
evaluation
metrics
until
finally
reaching
design
trichromatic
procedure.
herein
illustrated
work
represents
comparative
study
between
two
newly
developed
normal-phase
reverse-phase
HPTLC
methods
for
simultaneous
quantitative
determination
Remdesivir
(RMD),
Favipiravir
(FAV)
Molnupiravir
(MOL).
For
method,
employed
mobile
phase
consisted
ethyl
acetate:
ethanol:
water
(9.4:0.4:0.25,
v/v),
while,
procedure,
greener
was
consisting
(6:4,
v/v).
both
methods,
detection
wavelength
RMD
MOL
244
nm
while
FAV
detected
325
nm.
Both
were
validated
following
International
Council
Harmonisation
(ICH)
guidelines
with
respect
linearity,
range,
accuracy,
precision
robustness.
established
proved
be
linear
over
range
50-2000
ng/band
30–800
RMD.
excellent
linearities
high
values
correlation
coefficients
not
less
than
0.99988.
successfully
applied
three
drugs
their
bulk
form
pharmaceutical
formulations.
Furthermore,
thorough
integrative
designed
performed.
Analytical
Eco-Scale,
novel
Modified
Green
Procedure
Index
(MoGAPI)
(2024)
GREEnness
(AGREE)
greenness
recent
Blue
Applicability
Grade
(BAGI)
(2023)
tool
blueness
evaluation.
Finally,
RGB12
model
implemented
appraisal
whiteness
methods.
Language: Английский
Design of Experiment and green analytical chemistry principles for developing a robust and sustainable Stability-Indicating HPLC method for Bempedoic acid impurity profiling
Microchemical Journal,
Journal Year:
2024,
Volume and Issue:
207, P. 112133 - 112133
Published: Nov. 9, 2024
Language: Английский
A comprehensive review on niclosamide detection in foodstuffs and pharmaceutical preparations: Diverse analytical approaches and emerging techniques
Kalyani A. Birari,
No information about this author
Pravin O. Patil,
No information about this author
Shadma Wahab
No information about this author
et al.
Microchemical Journal,
Journal Year:
2024,
Volume and Issue:
unknown, P. 112284 - 112284
Published: Nov. 1, 2024
Language: Английский
Sensing of the COVID-19 antiviral molnupiravir in the presence of an anionic surfactant on the surface of a boron-doped diamond electrode in pharmaceutical formulation
Yunus Bedir,
No information about this author
Yavuz Yardım
No information about this author
Monatshefte für Chemie - Chemical Monthly,
Journal Year:
2024,
Volume and Issue:
unknown
Published: Dec. 17, 2024
Language: Английский
A novel Green systematic HPLC and UV-Spectroscopic method for the determination of rifaximin in tablet formulation
Research Square (Research Square),
Journal Year:
2024,
Volume and Issue:
unknown
Published: June 3, 2024
Abstract
A
sustainable
approach
has
been
devised
for
quantifying
rifaximin
in
pharmaceutical
products,
utilizing
both
spectrophotometric
and
HPLC
methods.
In
the
technique,
accurate
measurement
of
absorbance
at
296
nm
detection
wavelength
was
conducted
by
taking
water
acetonitrile
(1:1)
as
solvent.
For
method,
a
phenomenonex
C18
250
x
4.6mm,5µ
column
employed,
with
(1:1
v/v)
serving
mobile
phase.
Isocratic
separation
elution
technique
employed
rate
1
mL
per
minute,
nm.
These
methods
were
found
to
be
cost-effective,
quick,
eco-friendly,
straight
forward,
giving
an
analysis
20
minutes.
Application
these
products
yielded
results
free
from
matrix
interference,
statistical
comparison
showing
no
significant
differences
among
techniques.
Furthermore,
assessment
greenness
using
AGREE
software
highlighted
developed
methods'
is
environmental
friendliness,
which
rely
on
solvents
such
water.
findings
advocate
adoption
our
analyst-
environmentally-friendly
determination
tablet
formulation
over
presently
Language: Английский
Development of a gradient method for sulfamethoxazole, trimethoprim, isoniazid, and pyridoxine hydrochloride in rabbit plasma through QbD-driven investigation
K M Premsagar,
No information about this author
C Bhagyalakshmi,
No information about this author
Piyong Sola
No information about this author
et al.
Scientific Reports,
Journal Year:
2024,
Volume and Issue:
14(1)
Published: Oct. 28, 2024
The
current
study
developed
a
method
for
quantifying
four
drugs—Sulfamethoxazole,
Trimethoprim,
Isoniazid,
and
Pyridoxine—in
rabbit
plasma.
uses
gradient
liquid
chromatography
based
on
analytical
quality
by
design.
To
achieve
separation,
Eclip
Plus
C18
(250
mm
×
5
mm,
4.6
µm)
column
with
L1
packing
was
used,
analytes
were
detected
at
254
nm
ambient
temperature.
optimized
mobile
phase
consisted
of
50
mM
potassium
dihydrogen
phosphate
buffer
(pH
6.5)
Methanol.
concentration
Methanol
3%
(0–5
min),
15%
(5–15
55%
(15–27
until
the
end
30-min
runtime,
flow
rate
set
0.95
mL/min.
Control
Noise
Experimentation
used
to
screen
studies,
revealing
that
rate,
pH,
significantly
affected
attributes.
identified
critical
attributes
(resolution
asymmetric
factor)
target
profile.
A
central
composition
design
optimize
essential
parameters.
drugs
showed
peaks
retention
times
6.990
min
7.880
Pyridoxine,
15.530
Sulfamethoxazole,
26.890
respectively.
validated
linearity
in
range
10–640
ng
ml−1,
R2
0.9993,
0.9987,
0.9992
Language: Английский