Reddy, Gorla S.
ISOLATION AND CHARACTERISATION OF RAPAMYCIN, TEMSIROLIMUS REGIO ISOMER (MONOESTER) AND TEMSIROLIMUS DIESTER IN TEMSIROLIMUS DRUG - Vol.11(2) - M P Innovare Academic Sciences Pvt Ltd 2019 - 94-99p.
Objective:
Separation and identification of the process impurities in the manufacture of
temsirolimus drug viz., rapamycin, temsirolimus
regioisomer
(monoe
ster)
(TS monoester)
, and
temsirolimus diester
(TS diester)
.
Method
s:
During the process development of
temsirolimus (TS), three process impurities
-rapamycin,
temsirolimu
s regioisomer
(monoester) and
temsirolimus diester
-were detected by high
-performance
liquid chromatography (HPLC). I
mpurities were isolated by m
edium
pressure liquid
Chromatography (MPLC) and characterized by ESI
-MS/MS,
1
H NMR, FT
-IR spectral data.
Result
s:
These impurities are
characterised
with the help of ESI MS/MS,
1
H NMR,
and
FT
-IR data.
The impurities are identified
and
characterised
as
the process impurities.
One of them is the starting material
i.e.
rapamycin and the other two are formed during the manufacture of
the drug
. This
method offers advantages over using photodiode-
array UV detection (LC
-PDA) for the determination of peak purity, viz. components with similar
UV spectra can be distinguished.
Conclusio
n:
The structures of these impurities were characterized as r
apamycin, TS Monoester,
and
TS Diester. Out of these process impurities
,
rapamycin has been previously identified while the other two
are
previously unreported.
PHARMACEUTICS
ISOLATION AND CHARACTERISATION OF RAPAMYCIN, TEMSIROLIMUS REGIO ISOMER (MONOESTER) AND TEMSIROLIMUS DIESTER IN TEMSIROLIMUS DRUG - Vol.11(2) - M P Innovare Academic Sciences Pvt Ltd 2019 - 94-99p.
Objective:
Separation and identification of the process impurities in the manufacture of
temsirolimus drug viz., rapamycin, temsirolimus
regioisomer
(monoe
ster)
(TS monoester)
, and
temsirolimus diester
(TS diester)
.
Method
s:
During the process development of
temsirolimus (TS), three process impurities
-rapamycin,
temsirolimu
s regioisomer
(monoester) and
temsirolimus diester
-were detected by high
-performance
liquid chromatography (HPLC). I
mpurities were isolated by m
edium
pressure liquid
Chromatography (MPLC) and characterized by ESI
-MS/MS,
1
H NMR, FT
-IR spectral data.
Result
s:
These impurities are
characterised
with the help of ESI MS/MS,
1
H NMR,
and
FT
-IR data.
The impurities are identified
and
characterised
as
the process impurities.
One of them is the starting material
i.e.
rapamycin and the other two are formed during the manufacture of
the drug
. This
method offers advantages over using photodiode-
array UV detection (LC
-PDA) for the determination of peak purity, viz. components with similar
UV spectra can be distinguished.
Conclusio
n:
The structures of these impurities were characterized as r
apamycin, TS Monoester,
and
TS Diester. Out of these process impurities
,
rapamycin has been previously identified while the other two
are
previously unreported.
PHARMACEUTICS