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Dear friends,
We are now working on a bioequivalence study for risedronate tablet. For determination of residronate concentration in serum, we have been performing several methods including HPLC and LC-MS. However we didn't get satisfied data. I would like to a reliable validated method for it=92s determination in plasma. I should be most grateful.
Thank you very much
Dr. Mohamed Elsherbiny, M.D.
Chairman of the Board
Genuine Research Center GRC
http://www.grc-me.com
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Articles like this are available from Amazon.com Media Library for just $8.95, which is a fairly inexpensive alternative to ScienceDirect.
H.J. Jia, W. Li, K. Zhao
The College of Pharmaceuticals & Biotechnology, Tianjin University, Tianjin 300072, People's Republic of China
Analytica Chimica Acta
Volume 562, Issue 2, 15 March 2006, Pages 171-175
In the present work, an analytical method for determination of risedronate, a member of bisphosphonates, is described for the routine analysis in rat plasma. Sample pre-treatment involves protein precipitation, co-precipitation with calcium at alkaline pH, hydrolysis of possible derivatives of pyrophosphate and reprecipitation. A good separation was obtained by using a reversed- phase column (Hypersil ODS-2 C18, 4.6 mm =C3=97 250 mm, 5 =CE=BCm). The mobile phase was an aqueous solution of buffer (contained 1.5 mM EDTA-2Na, 1 mM sodium etidronate, 11 mM sodium phosphate and 5 mM tetrabutylammonium bromide as ion-pair reagent) =E2=80=93 methanol (88:12, v/ v) adjusted to pH 6.75 using 1 M NaOH. The flow rate was 1 ml min=E2=88=92 1. UV detection (=CE=BB = 262 nm) was used to quantitate risedronate in the concentration range of 10=E2=80=93500 ng ml=E2=88=921. The limit of detection and quantitation for risedronate were 7 and 10 ng ml=E2=88=921, respectively. The method was applied successfully t
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1) Talk to the manufacturer of residronate and ask for method details
2) Search NLM for residronate assays
There may be enough info to set the method, if not, you can get the
original
citation or write to the authors
3) Search column manufacturers Waters, Agilent, Phenomenex, the method
will
be available on line.
4) You can search for a CRO that has the method and might share it
with you
(least likely).
What exactly is your method and where does it fail?
Edward F. O'Connor, PhD
78 Marbern Drive
Suffield, CT 06078
efoconnor.at.cox.net
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