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ABSTRACT:
Analytical method development followed by method validation is an important process in the drug discovery. Although the drug shows good potency, lack of validated analytical method will not allow the drug to enter into the market. This is to ensure the quality and safety of the drug. The main objective of this review is to give an idea about the old and novel techniques available for the analysis of drugs in their raw material and formulated forms, check the stability of the drugs in the presence of the excipients and other stress conditions experienced during their shelf life period. Analytical methods development and validation play important roles in the discovery, development and Manufacture of pharmaceuticals. Method development is the process of proving that an analytical method is acceptable for use to measure the concentration of an API in a specific compounded dosage form which allows simplified procedures to be employed to verify that an analysis procedure, accurately and consistently will deliver a reliable measurement of an active ingredient in a compounded preparation.
KEYWORDS: Analytical method development, drug discovery, shelf life, active ingredient, compounded preparation.
INTRODUCTION:
ANALYTICAL METHOD DEVELOPMENT:
Analytical chemistry deals with methods for identification, separation, and quantification of the chemical components of natural and artificial materials. The choice of analytical methodology is based on many considerations, such as: chemical properties of the analyte and its concentration sample matrix, the speed and cost of the analysis, type of measurements i.e., quantitative or qualitative and the number of samples. A qualitative method yields information of the chemical identity of the species in the sample.
A quantitative method provides numerical information regarding the relative amounts of one or more of the analytes in the sample. The steps of method development and method validation1
Method development plan definition
Background information gathering
Laboratory method development, it includes various stages namely sample preparation, specific analytical
method, detection and data processing
Generation of test procedure
A well-developed method should be easy to validate.
A method should be developed with the goal to rapidly test preclinical samples, formulation prototypes, and commercial samples. There are five common types of analytical methods, each with its own set of validation requirements1
* Identification tests
* Potency assays
* Quantitative tests for impurities
*...