Optimisation And Method
Journal Title: International Journal of Engineering Sciences & Research Technology - Year 30, Vol 1, Issue 8
Abstract
One of the most critical factors in developing pharmaceutical drug substances and analytical test methods used to analyze pharmaceutical products should generate valid and meaningful data in terms of reliability, accuracy and precision, regardless of whether it is intended for acceptance, release, stability pharmacokinetic studies. Validation of an analytical method is a process that provides documented evidence that an analytical test method performs in an appropriate manner for the purposes for which it was intended. Method validation is a process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistence of analytical results; it is an integral part of any good a for method validation for compound evaluation.USP defines the steps for validation as accuracy, precision, linearity, ruggedness, robustness.
Authors and Affiliations
Mr. N. P. Karmarkar
Keywords
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