Chromatography Forum

By SOP on Saturday, August 28, 2004 - 02:14 am:

Dear all,
My question maybe funny for you but I am a beginner so I realy need a good start. I am developing an HPLC method, could any of you suggest me where I can find a good protocol to develop a method? I read many books but they are tooo general for me, I need the detailed protocol, e.g how many sample I have to prepare for calibration curve, what I have to do to test accuracy, specificity...and the requirements for RSD, for % recovery...
All your suggestions are greatly appreciated!

-------------------------------------------------------------------------------------------------------
By anon on Saturday, August 28, 2004 - 09:28 pm:

Hello SOP,

Try this link
http://www.bioqc.org/52

Good luck

-------------------------------------------------------------------------------------------------------
By anon on Saturday, August 28, 2004 - 09:42 pm:

Sorry about previous information, doesn't seem to work, try this one
http://www.bioqc.org/Leedoyeon030825.ppt

Thanks Anon,
The link really helps me to understand the basic ones. However, I still don't know how to calculate the LOD or LOQ. Could you pls clarify for me "standard deviation of blank readings " or "standard deviation of regression line", what I have to do to get this SD?
Thanks in advance!

LOD and LOQ are required only for validation of analytical methods for impurituies.

Links:
http://www.separationsnow.com/basehtml/ ... -0,00.html

A Practical Guide to Analytical Method Validation (Hits: 1542)
Paper in Analytical Chemistry (1996, 68, 305A - 309A), by J. Mark Green, principal research scientist at DuPont Merck Pharmaceutical, which emphasises the need to validate a method correctly, even though this might be tedious

Analytical Procedures and Method Validation (Hits: 2165)
Highlights of the FDA¿s Draft Guidance. Paper R. Rajagopalan in LC - GC, January 2001