UPLC Pyrantel Pamoate Method
Answers
-
Atif:
It will be interesting to see what people comment here.
If you are going to run exactly the same method on ACQUITY UPLC as HPLC, same column same mobile phase, its the same method, I do not think anything is called for, as you are simply using ACQUITY as a regular LC. It can be run as such.
Is this is your first ACQUITY in your lab? Have you been running for a while?
(When running an HPLC column do not forget to set your backpressure limit to correspond to HPLC column pressure limits. You can still use the reusable high pressure fittings and stabilizer). Note - you can measure your HPLC system volume as it will be larger than your ACQUITY UPLC. You may need to add a gradient hold to your first line of the gradient table equivalent to the additional volume. For example HPLC's are usually about 1 mL in volume, so if your method is running at 1 mL/min add a 1 min hold at the first line to add back the volume.The HPLC volume may play a role in the gradient separation. Try with and wiithout, to see if it is neede or not).
If you intend to scale to UPLC then after the method is successfully transferred, an equivalency study should be a consideration, a discussion with scientific affairs person at your company is best. However, there is a interesting discussion of the transfer of HPLC methods to UPLC methods by a senior manager of a FDA regulated company in the generics industry whose experience is pertinent.
http://www.waters.com/waters/library.htm?lid=10084046&cid=511436
For practical aspects of transferring an HPLC to UPLC method look at the discussion threads on "tailing problem" and "tailing problem part 2" where the discussion of a HPLC to UPLC transfer is discussed and the educational web casts on the overview page.
Liz
0 -
any thing true in HPLC is true in UPLC, 1st your question is incomplete you must provide all your LC conditions & some procedures, secondly you must paste your chromatograms, if you worked on HPLC before all possible in UPLC only you have to care in injection techniques of UPLC SM as well sample prep. bcuz I observe in many cases every thing was ok but sample overload, or wrong use of injections.
if a method present in USP,BP by HPLC then why not possible by UPLC (more rapid & robust tech)... I think you are doing some mistakes in your methods & it could be .. diluents, sample prep, injection modes etc.
method validation is not an easy task in pharma, requires lengthy work & too much documentations, initially whenever you succeed to develop a method you must PASS "System Suitability Test" like %RSD, USP Tailing factor etc. after that you can work on validation, but here I can only tell you about validation parameters you can get all details of ICH & FDA guidelines on their web sites & these are....>
SPECIFICITY
LINEARITY
ACCURACY
PRECISION
RANGE
LOD & LOQ
ROBUSTNESS
SYSTEM SUITABILITY TESTING
~~ Salman
0 -
Hi Liz,
Thanks for replying my question, you can say its my first UPLC experience but I also got invovled in other method (for that I also asked a question but I did not any reply), I got the same response from so many people but is there anything documented somewhere in FDA or etc that its not mendetory to validate any method transfer from HPLC to UPLC although we are doing equivalent study.
Thx
Atif
0 -
I think u did not get my question I told you that I am applying the same method considering the UPLC limitations ( like injection volume & etc.) so I know that what can happen if injection volume is improper so don't assume that I am making mistakes in my method just try to answer my question plz and I know abt the validation parameters its basic thing if you are working in R & D invironment, the main thing what I am asking is there any legal or regulatory document which states that there is no validation required when you are transfering same HPLC method to UPLC?
I think u did not get my question I told you that I am applying the same method considering the UPLC limitations ( like injection volume & etc.) so I know that what can happen if injection volume is improper so don't assume that I am making mistakes in my method just try to answer my question plz and I know abt the validation parameters its basic thing if you are working in R & D invironment, the main thing what I am asking is there any legal or regulatory document which states that there is no validation required when you are transfering same HPLC method to UPLC?
Thx
Atif
0 -
*No Matter What, you have to show your instrument is Qualified and the Method is Validated...!*
Dear Atif, in my knowledge there is no clue that validation is not mandatory for FDA, ICH or any regulatory bodies for HPLC method transfer to UPLC or RRLC
Actually FDA, USP or EP etc. depend on type of changes,
1-Major
2-Moderate
3-Minor &
LC technology change is in Minor change. In USP there are some limitations to change like column ID, pH, flow,temp. etc. so too many adjustments & modifications are there in UPLC method transfer. So adopting new tech. three things always important for cGMP
1-Verification (HPLC method with UPLC),
2- Equivalency (HPLC to UPLC tech.) ,
3- Robustness &
4- Validation ...
after that you have your SOPs, and according to FDA in Minor change applicant must submit their reports in Annual meting.
I think validation is required, because we received many methods from worldwide pharma by UPLC,RRLC with complete validated documents for drug registration.
Take care
~~ Salman
0
