By ac on Saturday, December 4, 1999 - 10:23 am:
I am using an HPLC method for the determination of related substances in a particular drug substance.No peak is visible except for the main peak injected at the conc. of 1000µg/ml.The drug product is found to be very stable and even treating it with 10N HCL or 10N NaoH or 30% H2O2 has no effect on the drug substance.All the intermediates have been checked individually and no peak of any of the intermediate is present in the sample.Now how can I be sure that my method for the determination of RS in that sample is correct or not?
By Anonymous on Sunday, December 5, 1999 - 08:17 pm:
Are you developing the method or following a published regulatory method?
By ac on Tuesday, December 7, 1999 - 06:56 am:
I am using an In-house method
By Anonymous on Tuesday, December 7, 1999 - 10:31 am:
Have you tried spiking your 1000ug/ml main peak sample at multiples of your "expected" levels of RS?
i.e. spike individually and collectively (in different aliquots of course) at levels of say 1, 5, 10 times your expected level of impurities or related substances, this should also have the added benefit of giving you data useable in method validation to show there are no interferences from impurities, formulants, &c.
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