Bioanalytical method development and alidation of ibrutinib in biological matrices by LC-MS/MS
By: Hepsebah, N. J. R
.
Contributor(s): Ashok Kumar, A.
Publisher: M P Innovare Academic Sciences Pvt Ltd 2019Edition: Vol. 2(3).Description: 22-26p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
Pawar, Shweta Formulation and evaluation of garlic powder loaded floating matrix tabletSummary: Objective:
The main aim
of the research was to develop
a fast and highly sensitive bioanalytical LC-
MS/MS
technique
for the quantitation
of
ibrutinib
in
human
plasma
.
Method
s:
Chromatography
has
achieved
on
a reverse
phase
-symmetry C
, A. ASHOK KUMAR
Mewar University, Chittorgarh, Rajasthan, India
Emai
l: jessie.hepsebah@gmail.com
18
(75
mm
× 4.6
mm, 3.5
μm) column with gradient elution by acetonitrile,
methanol and 0.1
%
v/v
formic acid as
the
mobile
phase. Chromatographic peaks were resolved with 0.7 m
l/min
flow rate
. Drug
was extracted with
ethyl acetate solvent by liquid
-liquid extraction method.
Monitoring of transition of m/z 441.2 and 55.
01 for ibrutinib
and 446.5 and 60.01 for
Ibrutinib
-D5
were made on multiple reaction monitoring.
Result
s:
Calibration
curve of ibrutinib
was linear over 1
-600 ng/ml
concentration range with a
regression
coefficient (r
2
Keyword
s:
Ibrutinib
,
Chronic lymphocytic leukemia, LC
-MS/MS, FDA guidelines and Dilution integrity
) value of
>0.99
. The % RSD
values were less than 8.5% for inter
-day and intra
-day precision and accuracy. The method has excellent recovery and the percentage recovery values of
lower quality control (LQC)
, median quality control (
MQC
) and
higher quality control (
HQC
) samples
were 101.86%, 102.8%
, and
99.28
% respectively
.
Conclusio
n:
The drug was stable for more time at variable
stability conditions and method was successfully applicable
to
the
regular
analysis of
ibrutinib
in biological matrices
| Item type | Current location | Call number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|
Articles Abstract Database
|
School of Pharmacy Archieval Section | Not for loan | 2018555 |
Objective:
The main aim
of the research was to develop
a fast and highly sensitive bioanalytical LC-
MS/MS
technique
for the quantitation
of
ibrutinib
in
human
plasma
.
Method
s:
Chromatography
has
achieved
on
a reverse
phase
-symmetry C
, A. ASHOK KUMAR
Mewar University, Chittorgarh, Rajasthan, India
Emai
l: jessie.hepsebah@gmail.com
18
(75
mm
× 4.6
mm, 3.5
μm) column with gradient elution by acetonitrile,
methanol and 0.1
%
v/v
formic acid as
the
mobile
phase. Chromatographic peaks were resolved with 0.7 m
l/min
flow rate
. Drug
was extracted with
ethyl acetate solvent by liquid
-liquid extraction method.
Monitoring of transition of m/z 441.2 and 55.
01 for ibrutinib
and 446.5 and 60.01 for
Ibrutinib
-D5
were made on multiple reaction monitoring.
Result
s:
Calibration
curve of ibrutinib
was linear over 1
-600 ng/ml
concentration range with a
regression
coefficient (r
2
Keyword
s:
Ibrutinib
,
Chronic lymphocytic leukemia, LC
-MS/MS, FDA guidelines and Dilution integrity
) value of
>0.99
. The % RSD
values were less than 8.5% for inter
-day and intra
-day precision and accuracy. The method has excellent recovery and the percentage recovery values of
lower quality control (LQC)
, median quality control (
MQC
) and
higher quality control (
HQC
) samples
were 101.86%, 102.8%
, and
99.28
% respectively
.
Conclusio
n:
The drug was stable for more time at variable
stability conditions and method was successfully applicable
to
the
regular
analysis of
ibrutinib
in biological matrices
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