AN OVERVIEW OF ANALYTICAL METHOD VALIDATION
نویسندگان
چکیده
منابع مشابه
Analytical Method Validation: An Updated Review
The development of sound Analytical method(s) is of supreme importance during the process of drug discovery, release to market and development, culminating in a marketing approval. The objective of this paper is to review the method development, optimize and validation of the method for the drug product from the developmental stage of the formulation to commercial batch of the product. Method d...
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In pharmaceutical industries, the validation of analytical methods is used to demonstrate that the method is fitted for its purpose; it must follow a plan which includes scope, performance characteristics, and acceptance limits. Analytical methods need to be validated or revalidated prior to their introduction into routine analyses (release of batch). The overarching philosophy in current good ...
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A fast and simple modified QuEChERS (quick, easy, cheap, rugged and safe) extraction method based on spiked calibration curves and direct sample introduction was developed for determination of benzo[a]pyrene (BaP) in bread by gas chromatography-mass spectrometry single quadrupole selected ion monitoring (GC/MS-SQ-SIM). Sample preparation includes extraction of BaP into acetone followed by clean...
متن کاملValidation of an Analytical Method for Determination of Benzo[a]pyrene Bread using QuEChERS Method by GC-MS
A fast and simple modified QuEChERS (quick, easy, cheap, rugged and safe) extraction method based on spiked calibration curves and direct sample introduction was developed for determination of benzo[a]pyrene (BaP) in bread by gas chromatography-mass spectrometry single quadrupole selected ion monitoring (GC/MS-SQ-SIM). Sample preparation includes extraction of BaP into acetone followed by clean...
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ژورنال
عنوان ژورنال: Universal Journal of Pharmaceutical Research
سال: 2020
ISSN: 2456-8058
DOI: 10.22270/ujpr.v5i1.362