Levetiracetam related substance by HPLC

Dear all.
We are analysing levetiracetam samples as per IP Monogram. As per IP mobile phase is 0.196% Sulphuric acid 40mL and acetonitrile 960mL.
Column using INERTSIL-ODS3V,
As per IP Retention time is 10.0min but we are getting 2.7min.
We are tried on Kromasil, YMC, and other ODS columns but same result getting.
Please guide me in this issue.
A. Prabhakar,

You can adjust flow rate of mobile phase or make little adjustment in the percentage composition of mobile phase to get satisfactory resolution of peaks and expected Retention time. Also, please check length of column used. The retention time given in pharmacopoeias is just a guidance value. I am sure you must have done method validation / suitability.

Dear Mr.Prabhakar,

If you have sure then send one mail to respective pharmacopeia. And you can develop and validate the method by using different column , different chromatographic system and after validation yo can send data to pharmacopeia.


1 Like

Dear prabhakar i think the predicament related to mobile phase and column alignment and check your mobile phase preparation. 0.196 % sulfuric acid.
Same type of RT related concern precived before couple of week due to analyst used 10N sulfuric acid instead or sulfuric acid please check possibility.