Bioequivalence and Bioavailability Forum

Dear Sadia!

❝ [...] i am doin this to complete my m.phill project, i am not getting any

❝ kind of help from my university only that my teachers told me to so

❝ Bioequivalence study as it is good and helpful for me that i do job in an

❝ industry,

What support do you get from your teachers except suggesting to perform a BE study?!

❝ my teachers says that the most tough thing is to develope a method for

❝ HPLC study of drug in plasma it can take 3 months to 3 years, is that

❝ true?

I would go with cefaclor (little bit easier ). A simple HPLC-method with UV detection at 265nm is sufficient (even a fixed wavelength detector at 254nm would do the job). Aim for a linear range of 0.3-30µg/mL plasma (assuming a 500mg dose). It's important to put blood samples until centrifugation in an ice bath and stabilize plasma afterwards (3mL plasma + 150µL 50% acetic acid) to prevent degradation by hydrolysis. If you have no experience with bioanalytical method development and validation 3+ months is realistic, 3 years is nonsense.

❝ and if the drug study method is already developed by other persons can i

❝ use that method or i should have to develop a new method for my study?

No need to reinvent the wheel. Search the literature - but be aware that almost no published method 'works' as described; modifications are the rule. Forget about all the fancy LC/MS-MS stuff and look for older ones. You can combine sample preparation of a newer method (solid phase extraction works perfectly for cephalosporins) with chromatographic conditions (column type, mobile phase) of an old HLPC/UV method. Don't fiddle around with protein precipitation or liquid-liquid-extraction if you are a beginner.

❝ Kindly help me i really do not have any idea to do my research

He who seeks for methods without having a definite problem in mind
  seeks in the most part in vain.  David Hilbert

It's your MPhil, not mine. If you want to get a job in the industry later on, you must do some homework first. Maybe my lectures (covering the clinical, analytical, and statistical parts) help. Go for the most recent ones (Ljubljana 2010).
I have some studies in my files; if you have more specific questions feel free to come back - giving your ideas first.