A REVIEW ON ANALYTICAL METHOD DEVELOPMENT AND METHOD VALIDATION
Journal Title: Int J of Preclin & Pharm Res - Year 2012, Vol 2, Issue 1
Abstract
ABSTRACT This article presents a review on chromatography and method validation applied to the determination of various pharmaceuticals is discussed. It describes about various Chromatographic techniques and its method validation. Also it briefly describes about the different types of chromatographic techniques and HPLC method validation parameters. The primary objective of validation is to form a basis for written procedure for production and process control which are designed to assure that the drug products have the identity, strength, quality and purity they purport or are represented to possess quality, safety and efficacy must be designed to build into the product. Each step of the manufacturing process must be controlled to maximize the probability that the finished products meet all quality and design specification. Keywords: Chromatography, HPLC, Method Validation, Method development, ICH Guidelines.
Authors and Affiliations
*T. Yugandharudu, M. Surendra, T. Viswasanthi
Keywords
Related Articles
- EP ID EP149175
- DOI -
- Views 141
- Downloads 0
CAPILLARY ELECTROPHORESIS INDUCTIVELY COUPLED MASS SPECTROMETRY
ABSTRACT Capillary electrophoresis (CE) is a separation technique in which the analytes are separated on the basis of differences in their charge-to-size ratios. This makes CE especially suitable for the analysis...
SIMULTANEOUS QUANTIFICATION OF EPIGALLOCATECHIN-3-GALLATE AND ATORVASTATIN BY USING HPLC-UV METHOD AND ITS APPLICATION TO PHARMACOKINETIC STUDIES IN RATS
ABSTRACT A sensitive, precise and simple LC method for the simultaneous quantification of epigallocatechin-3-gallate and atorvastatin in rat plasma has been developed and validated. The chromatographic separation w...
FLASH CHROMATOGRAPHY AND ITS ADVANCEMENT: AN OVERVIEW
ABSTRACT Flash chromatography is widely used for purification of low molecular weight natural compounds and products of organic synthetic reactions. Modern flash techniques include the use of convenient disposable...
RECENT APPROCHES FOR IMPURITY PROFILING IN PHARMACEUTICAL FORMULATIONS
ABSTRACT In the pharmaceutical world, an impurity is considered as any other organic material, besides the drug substance, or ingredients, arise out of synthesis or unwanted chemicals that remains with API’s. The...
AN OVERVIEW ON FOURIER TRANSFORM MASS SPECTROMETRY
ABSTRACT This article provides an introduction to Fourier transform-based mass spectrometry. The key performance characteristics of Fourier transform-based mass spectrometry, mass accuracy and resolution, are prese...