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
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