The Role of and the Place of Method Validation in Drug Analysis Using Electroanalytical Techniques

ABSTRACT

Electroanalytical methods are chosen for the sensitive analysis of pharmaceutically active compounds in their dosage forms and biological samples. Electroanalytical method validation is the process used to confirm that the determination procedure employed for a specific test is suitable for its intended use like other analytical methods. Results from electroanalytical method validation can be used to judge the quality, applicability, accuracy, reliability and consistency of analytical results; it is an integral part of any analytical procedure. Also in electroanalytical drug analysis, important decisions are taken which are based on data obtained from real samples. Validation parameters help assure that the electroanalytical methods ensure the correct identity, strength, quality, accurate, precise, selective, robust and sensitive. A well-defined and well-documented validation process provides regulatory agencies with evidence that the system and method suitable for its intended use. Method validation is an essential component of the measures that a laboratory should implement to permit it to produce reliable electroanalytical data.