DEVELOPMENT AND VALIDATION OF SENSITIVE LC-ESI-MS/M S METHOD FOR THE SIMULTANEOUS ESTIMATION OF DAPAGLIFLOZIN AND SAXAGL IPTIN IN HUMAN PLASMA
By: Adluri, Phanindra
.
Contributor(s): Shravan Kumar Y.
Publisher: M P Innovare Academic Sciences Pvt Ltd 2019Edition: Vol.11(4).Description: 55-59p.Subject(s): PHARMACEUTICSOnline resources: Click here
In:
International journal of pharmacy and pharmaceutical scienceSummary: Objective
:
To develop and validate a sensitive liquid chromato
graphy-electrospray ionization-tandem mass spectrom
etric (LC-ESI-MS/MS)
technique for the quantification of dapagliflozin a
nd saxagliptin in plasma by linagliptin as internal
standard.
Methods
:
Chromatography was achieved on hypersil C
18
(50 mmx4 mm) 5 μ analytical column with 0.1% formi
c acid and acetonitrile (25:75 V/V)
as mobile phase at 0.7 ml/min flow rate. Dapagliflo
zin, saxagliptin, and linagliptin were detected at
m/z 409.14/135.0, m/z 316.2/180.13 and m/z
472.54/456.21 respectively. Drugs and internal stan
dard were extracted by LLE (liquid-liquid extractio
n).
Results
:
Developed technique was validated over 0.5-1500.0 n
g/ml linear concentration range for dapagliflozin a
nd 2.00-2000.0 ng/ml for
saxagliptin. This method established with intra-bat
ch and inter-batch precision within 2.44-8.12% and
1.25-7.14 % for dapagliflozin and 1.84-7.5 %
and 1.02–6.00 % for saxagliptin. This method establ
ished with intra-batch and inter-batch accuracy for
dapagliflozin within 98.86-103% and 96.98-
102 % respectively and for saxagliptin within 98.05
-109.06 % and 97.00-104.00 % respectively.
Conclusion
:
Both dapagliflozin and saxagliptin were stable duri
ng three freeze-thaw cycles, long term and bench-to
p stability studies. The
developed method was useful for the routine analysi
s of dapagliflozin and saxagliptin simultaneously i
n plasma samples.
| Item type | Current location | Call number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|
Articles Abstract Database
|
School of Pharmacy Archieval Section | Not for loan | 2020909 |
Objective
:
To develop and validate a sensitive liquid chromato
graphy-electrospray ionization-tandem mass spectrom
etric (LC-ESI-MS/MS)
technique for the quantification of dapagliflozin a
nd saxagliptin in plasma by linagliptin as internal
standard.
Methods
:
Chromatography was achieved on hypersil C
18
(50 mmx4 mm) 5 μ analytical column with 0.1% formi
c acid and acetonitrile (25:75 V/V)
as mobile phase at 0.7 ml/min flow rate. Dapagliflo
zin, saxagliptin, and linagliptin were detected at
m/z 409.14/135.0, m/z 316.2/180.13 and m/z
472.54/456.21 respectively. Drugs and internal stan
dard were extracted by LLE (liquid-liquid extractio
n).
Results
:
Developed technique was validated over 0.5-1500.0 n
g/ml linear concentration range for dapagliflozin a
nd 2.00-2000.0 ng/ml for
saxagliptin. This method established with intra-bat
ch and inter-batch precision within 2.44-8.12% and
1.25-7.14 % for dapagliflozin and 1.84-7.5 %
and 1.02–6.00 % for saxagliptin. This method establ
ished with intra-batch and inter-batch accuracy for
dapagliflozin within 98.86-103% and 96.98-
102 % respectively and for saxagliptin within 98.05
-109.06 % and 97.00-104.00 % respectively.
Conclusion
:
Both dapagliflozin and saxagliptin were stable duri
ng three freeze-thaw cycles, long term and bench-to
p stability studies. The
developed method was useful for the routine analysi
s of dapagliflozin and saxagliptin simultaneously i
n plasma samples.
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