Abstract
The development of sound Analytical method 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.The purpose of this validation is to show that processes involved in the development and manufacture of drug, production and analytical testing can be performed in an effective and reproducible manner. This review article provides guidance on how to perform validation characteristics for the analytical method which are utilized in pharmaceutical analysis.
 Keywords: Analytical method validation, Pharmaceutical analysis, Specificity, Precision, Accuracy.
Highlights
High Performance Liquid Chromatography (HPLC) is one of the most used analytical techniques
HPLC acquires a high degree of versatility not found in other chromatographic systems and it has the ability to separate a wide variety of chemicalmixtures[1]
In years current development of the analytical methods for recognition, clarity evaluation and quantification of drugs has received a great deal of notice in the field of pharmaceutical analysis
Summary
High Performance Liquid Chromatography (HPLC) is one of the most used analytical techniques. Chromatographic process can be defined as separation technique involving mass-transfer between stationary and mobile phase. HPLC utilizes a liquid mobile phase to separate the components of a mixture. The stationary phase can be a liquid or a solid phase This component are first dissolved in a solvent, and forced to flow through a chromatographic column under a high pressure. The interaction of the solute with mobile and stationary phases can be manipulated through different choices of both solvents and stationary phases. HPLC acquires a high degree of versatility not found in other chromatographic systems and it has the ability to separate a wide variety of chemicalmixtures[1]
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