While selecting a drug and its dosage form for its in vitro dissolution method development and validation by HPLC, what are the things to kept in mind?
Please specify precisely what you want to know. If you have any generic drug in hand, in that case, at first you must collect the innovator's drug for comparison and it is mandatory. Find out the overall behavior of that drug in different types of dissolution media, e.g. pH 1.2, 4.5, 6.8 etc at different time intervals. Then use that response as reference for your future studies. Moreover, the pKa value, absorption site etc of the API also play vital roles to find out the exact dissolution medium. And, validation of any analytical method is usually performed by following ICH Q2(R1) guidelines.
You don't select a drug in order to make a trouble-free dissolution method with HPLC quantitation, you select a drug because it appears pharmacologically promising! The stuff about media changes, etc. is only relevant if your drug requires delivery in the small intestine or is intended to release slowly; then you'd simulate the human digestion process in order to demonstrate such effective release. As far as dosage forms: excipients etc. may interfere with HPLC, but a sample filtration and proper precolumn may filter them out. Watch out for stuff building up on that precolumn, however! -- and I've seen also a case where an entire analytical method was validated for a drug, and then the pump started failing for its next type of analysis because the pump post-solvent-mixing-inline-filter (yes, there is one) was coated with residues from the solvents used (note, not even from excipients in the injected samples)!
The test drug have to undergo dissolution test through various solvent to determine which of these products will be suitable for the test in question.
HiMs.Madhavi
In spite of all as a general consideration feasibility is the major factor you need to keep in mind. It includes what you need and what you have in all aspects and the level of your research along with the outcome which has to be compared with them.
In addition I hope the following link may give you some information related to what you are looking for.
Wish you Good Luck
http://www.dissolutiontech.com/DTresour/201311Articles/DT201311_A03.pdf
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