I have a compound called Ziprasidone, which is not dissolving any of the regularly used diluents like DMA,DMSO,DMF,Imidazolidinone etc... w.r.t 20mg/ml concentration.
Can anybody give suggestion on diluent selection for such cases.
I found the compound is soluble at a concentration of 5mg/ml in one of the above solvents for RS/OVI analysis by GC. Can I go ahead for the method validation with 5mg/ml concentration?
Is it acceptable for regulatory authorities or any queries will come?
Can anybody advice please.
Thanks in advance.
By Anonymous on Thursday, March 25, 2004 - 05:04 am:
Ask the regulatory authorities. Don't ask nameless Internet folks. Who will you answer to if we are wrong here?
You might try add water to the organic solvent you have chosen for your HCl? salt. I have done validations on a cocaine variant that only went into solution with a 50/50 Dimethylacetamide/water dissolution solvent
If you are doing the free base you might want to consider using a dilute acid, even a buffer.
By Anonymous on Tuesday, June 1, 2004 - 09:41 pm:
Would any one give me literature information on Ziprasidone HPLC analysis, I have been searching the net, however considering the instruments we have at the lab I could hardly get any relevant information. I seek your help.