09-05-2012, 06:44 PM
i am a student end i want ppts of analytical method development for new formulation
09-05-2012, 06:44 PM
i am a student end i want ppts of analytical method development for new formulation
21-07-2012, 11:22 AM
Analytical method development
Analytical method development.pptx (Size: 758.39 KB / Downloads: 57) Basic criteria for new method development of drug analysis: The drug or drug combination may not be official in any pharmacopoeias A proper analytical procedure for the drug may not be available in the literature due to patent regulations Analytical methods may not be available for the drug in the form of a formulation due to the interference caused by the formulation excipients Analytical methods for the quantitation of the drug in biological fluids may not be available Analytical methods for a drug in combination with other drugs may not be available The existing analytical procedures may require expensive reagents and solvents. It may also involve cumbersome extraction and separation procedures and these may not be reliable. What does analytical methodology provide to an analyst ? » The required data for a given analytical problem » The required sensitivity » The required accuracy » The required range of analysis » The required precision i.e. the minimum requirements which essentially are the specifications of the method for the intended purpose: To be able to analyse the desired analyte in different matrices with surety and certainity. The method development and validation processes ● Method development plan ● Background information gathering ● Laboratory method development ● Generation of test procedure ● Method validation protocol ● Laboratory methods validation ● Validated test method generation ● Validation report. |
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