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sadia.amin ☆ 2010-07-19 00:38 (5805 d 20:42 ago) Posting: # 5651 Views: 6,599 |
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Hi, i need guidance for method development for HPLC study of plasma, i have not started my research yet and have many question in my mind. For HPLC study can i use the methods given in pharmacopoeia or i have to develop my own method, and is that easy to develop a method? i really need the answers kindly help me Edit: Category changed. [Helmut] |
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ElMaestro ★★★ Denmark, 2010-07-19 01:22 (5805 d 19:59 ago) @ sadia.amin Posting: # 5652 Views: 5,733 |
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Hi sadia.amin, ❝ i need guidance for method development for HPLC study of plasma, i have ❝ not started my research yet and have many question in my mind. For HPLC ❝ study can i use the methods given in pharmacopoeia or i have to develop my ❝ own method, and is that easy to develop a method? You are free to choose whatever method you like, it "just" needs to be validated. A pharmacopoeial entry may give you a good hint about an appropriate method, but the biological complexity is usually not reflected in it. If I were you my priority list would be: 1. Name the compound and ask in this forum if other have experience with it and what method they use. 2. Literature searches (including animal studies). 3. Ask at your API source. 4. Get inspiration from pharmacopoeias. Best regards EM. — Pass or fail! ElMaestro |
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sadia.amin ☆ 2010-07-26 15:43 (5798 d 05:37 ago) @ ElMaestro Posting: # 5677 Views: 5,671 |
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well thnx for reply, actully i am intrested in bioequivalance study of cefaclor or cefixime. My frind was told me tht drugs with shorter half life and good bioavailability are best for this study. is that true? i do work in a pharmaceutical firm so want to comparison our cefaclor or cefixime with other leader brands, by this way i also wan complete my m.phil pharmacology project. so plz tell me is tht easy to do i was read tht 14 volunteers are required for this this study plz kindly guide me how many minimum volunteers are required for the study |
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Helmut ★★★   Vienna, Austria, 2010-07-26 16:29 (5798 d 04:52 ago) @ sadia.amin Posting: # 5679 Views: 6,047 |
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Dear Sadia, please read this post first! ❝ actully i am intrested in bioequivalance study of cefaclor or cefixime. ❝ My frind was told me tht drugs with shorter half life and good ❝ bioavailability are best for this study. is that true? Your friend is probably wrong. Finding a sampling schedule for drugs with short half lives can be quite challenging. Define 'good bioavailability'. There are drugs with quite high first pass matabolism (i.e., low absolute bioavailability) which still show only moderate variability. But your friend is right that drugs with high absorption are generally easier to handle. ❝ i do work in a pharmaceutical firm so want to comparison our cefaclor or ❝ cefixime with other leader brands, Is you drug already marketed? Bioequivalence means the comparison of a test product with the inovator. Or do you want to run such a study just for fun (=marketing purposes). ❝ i was read tht 14 volunteers are required for this this study plz kindly ❝ guide me how many minimum volunteers are required for the study  the literature for previous studies. Both drugs show low variability for AUC and moderate for Cmax. If your regulation does not allow widening of the acceptance range for Cmax (from 0.80-1.25 to 0.75 to 1.33) a sample size of 14 subjects will be too low. BTW, the regulatory acceptance of widening is doubtful for a drug with low variability.— Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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sadia.amin ☆ 2010-07-26 22:26 (5797 d 22:55 ago) @ Helmut Posting: # 5683 Views: 5,815 |
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thanx Helmut Schütz for your reply, the information you gave are really useful, well im not doing this Bioequivalence study for marketing purposes, but 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, and i do not even know how to start my resreach, what first step i should follow to do, the drugs cefexime and cefaclor i just chose due to their shorter half life and good bioavailability in body, other wise i dont have any idea to do, 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? 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? Kindly help me i really do not have any idea to do my research |
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Helmut ★★★ Vienna, Austria, 2010-07-27 03:43 (5797 d 17:38 ago) @ sadia.amin Posting: # 5684 Views: 5,709 |
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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 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. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Jagdish Bairagi ☆ 2010-07-27 18:18 (5797 d 03:03 ago) @ sadia.amin Posting: # 5693 Views: 5,480 |
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Hi,sadia for the method development of x analyte ,first upall u will do the method deveopment yourself becouse lot of method availabe on net but u do yourself from refrencing try different mobile phase and different extraction to develop good method,in this way your confidance increase.As in HPLC UV THE MAIN PROBLEM OF METHOD DEVELOPMENT IN INTERFERANC IN PLASMA SAMPLES. |
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Helmut ★★★ Vienna, Austria, 2010-07-27 18:39 (5797 d 02:41 ago) @ Jagdish Bairagi Posting: # 5695 Views: 5,532 |
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Dear Jagdish, please read this post first ❝ As in HPLC UV THE MAIN PROBLEM OF METHOD DEVELOPMENT IN INTERFERANC IN PLASMA ❝ SAMPLES. Sorry, but this statement is nonsense. Sadia needs a method with an LLOQ of 0.3µg/mL. Do you really think that no validated methods existed before the era of LC/MS-MS? Actually I have a method in my files, it's not complicated at all. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz