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Central composite design based stability-indicating RP-HPLC method development and validation for the concurrent determination of Avutometinib and Defactinib in bulk and co-pack formulation with application to forced degradation studies
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DOI：10.1016/j.microc.2026.119337.png)
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Abstract
En 中文
• The AQbD-developed RP-HPLC method was utilized to determine Avutometinib and Defactinib simultaneously in bulk and co-pack formulation. • Method optimization was done using Central Composite Design. • The retention times were 2.717 min and 3.968 min respectively resulting in an efficient separation. • Quantitative analytical performance characteristics of the developed method including the linearity as seen from R2 values of 0.999 for both analytes in the range of 12.5–75.0 μg/mL, High precision with %RSD < 2%, accuracy (99–101% recovery), and sensitivity (LOD and LOQ: 0.60 and 2.00 μg/mL). • Forced degradation studies carried out inorder to prove the stability indicating ability of API's and co-pack formulations.
Keywords:
Avutometinib
Defactinib
Central composite design
Analytical quality by design
Design of experiments
Critical method parameter
Forced degradation
ACN
,
Acetonitrile
ANOVA
,
Analysis of Variance
HPLC
,
High Performance Liquid Chromatography
ATP
,
Analytical Target Profile
CCD
,
Central Composite Design
CMA
,
Critical Method Attribute
CMP
,
Critical Method Parameter
AQbD
,
Analytical Quality by Design
DoE
,
Design of Experiments
CQA
,
Critical Quality Attribute
ICH
,
International Council for Harmonisation
LOD
,
Limit of Detection
LOQ
,
Limit of Quantification
mL/min
,
Millilitres per minute
OPA
,
Orthophosphoric Acid
λmax
,
Wavelength of Maximum Absorbance
PDA
,
Photodiode Array Detector
RP-HPLC
,
Reverse Phase High Performance Liquid Chromatography
S/N
,
Signal to noise ratio
RT
,
Retention Time
TF
,
Tailing Factor
MAPK
,
Mitogen activated protein kinase signaling pathway
KRAS
,
Kirsten rat sarcoma viral oncogene homolog
BRAF
,
V-Raf murine sarcoma oncogene homolog B1
NRAS
,
Neuroblastoma rat sarcoma viral oncogene homolog
MEK
,
Mitogen activated protein kinase
ERK
,
Extracellular signal
FAK
,
Focal adhesion kinase
v/v
,
Volume/Volume
QbD
,
Quality by Design
°C
,
Degree Celsius
μg/mL
,
Micrograms per milliliter
%RSD
,
Percentage Relative Standard Deviation
Journal
IF:
5.1
Papers:
1.8W
Citations:
3.7W
Organization
No organization information available
Cited Papers