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Dear All,
My query is whether there is any regulatory concern for parameters
that should be tested for doing system suitability for LC-MS? and
In case we are analyzing both analyte and metabolite in matrix, is it
required to do system suitability for both?
Please give your valuable suggestions and some references
Thanks and regards.
M.S.Kohli
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The following message was posted to: PharmPK
Dear Manpreet
System suitability should be done initially for both analyte and the
metabolite, taking into consideration:
1) Carry over in either case
2) Stability of both analyte/metabolite and internal standard in
dilution solution
In both the cases mentioned above the system suitability can fail.
If the method is validated, one analyte SS suffices the purpose
(system is working fine). Based on sensitivity of the instrument,
inter-day variability in response, it is advisable to run SS for both
analyte and the metabolite.
Regards
Gurpreet Saini
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Hello everyone,
I agree with Mr. Saini Gurpreet and in addition to this I would
strongly recommend adding the injection of the LOQ to show that you
have sensitivity. Also make sure that your Reference LOQ for the
system suitability will take in consideration the recovery of the
analytes
This way your system suitability would demonstrate accuracy/
precision, carry over and sensitivity.
Comments/remarks are welcome
Best regards,
Sylvain Mandeville, Ph.D.
Lab Research
www.labresearch.com
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Dear Manpreet,
It is advisable to carry system suitability for all the analytes
including Internal standard especially when you are using LC-MS. The
system itself is very sensitive and takes sometime to equillibrate.
Injecting the system suitability can confirm the readiness of the
system. Also day to day variation in response can also be judged.
I think variation in parameters such as peak area response and
retention time can be checked for the acceptence of system suitability
Dr. Mandar Mote
Head Bio-analytical
Cadila Pharmaceuticals Ltd.
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The following message was posted to: PharmPK
Dear Dr. Mote:
It is certainly good advice to perform System Suitability Analyses on
all analytes including internal standards whether or not one is
referring to LC/MS.
However in the BioAnalytical and Pharmaceutical Analytical
Laboratories that I am most familiar with, variation in parameters
such as peak area response and
retention time has never been considered rigorous enough to be
compliant with system suitability requirements.
It is much better and more acceptable to use separation data with
similar analytes or with known impurities/degradants.
Vincent S. Venturella, Ph.D.
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Dear MS Kohli,
System suitability is not a guideline driven parameter, but this
parameter is must before starting any analytical run for analyte and
metabolite.
regards--
Raghavendra Shetty
Manipal AcuNova LTD
Manipal
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