2021
DOI: 10.9734/jpri/2021/v33i46a32872
|View full text |Cite
|
Sign up to set email alerts
|

Application of Elements of Quality by Design to Development and Optimization of HPLC Method for Fingolimod

Abstract: Purpose: A HPLC method for Fingolimod was developed using a Quality by Design concept. QbD has gained importance in recent times due to regulatory requirements. Actual study was started after determination of target profile and qualification of instrument. Methods: Separation was carried on a Grace C-8 column (4.6 x 250 mm, 5-μm particle size).The composition of mobile phase was methanol and 20 mM ammonium formate buffer of pH5.8 in gradient mode HPLC method development is affected by critical factors li… Show more

Help me understand this report

Search citation statements

Order By: Relevance

Paper Sections

Select...
2
1

Citation Types

1
2
0

Year Published

2022
2022
2023
2023

Publication Types

Select...
2

Relationship

1
1

Authors

Journals

citations
Cited by 2 publications
(3 citation statements)
references
References 6 publications
1
2
0
Order By: Relevance
“…In light of our experimentation, it was discovered that the retention times for the formulation in question were 7.53 and 7.52 min (Supplementary Figure S1B,C). The results confirmed that this method was validated with respect to every aspect of the experiment, including stability, accuracy, precision, and linearity [19].…”
Section: Evaluation Of Quantificationsupporting
confidence: 66%
“…In light of our experimentation, it was discovered that the retention times for the formulation in question were 7.53 and 7.52 min (Supplementary Figure S1B,C). The results confirmed that this method was validated with respect to every aspect of the experiment, including stability, accuracy, precision, and linearity [19].…”
Section: Evaluation Of Quantificationsupporting
confidence: 66%
“…The mobile phase was composed of 90% acetonitrile and 10% 20 mM ammonium formate buffer (pH 5.8). [45] The loading content of FTY720 in nanoparticles was calculated as loading…”
Section: Methodsmentioning
confidence: 99%
“…The mobile phase was composed of 90% acetonitrile and 10% 20 mM ammonium formate buffer (pH 5.8). [ 45 ]…”
Section: Methodsmentioning
confidence: 99%