Authors : MD Nazmus Sakib Chowdhury
Volume : 10
Issue : 1
Year : 2023
Page No : 28-30
A specific and sensitive analytical method development and validation plays an important role for building drug discovery, product development and manufacturing of pharmaceuticals. The main purpose of this review article is to check the report of specific and sensitive analytical method development and validation parameters involved in different pharmaceuticals manufacturing. Development of sensitive analytical method is extremely much significant because it ensures product efficacy and product quality. The sensitive analytical method development and validation is the process of proving that the analytical method meets the analytical acceptance criteria and it can use to measure the concentration of target molecule at its specification limit. The aim of method development is to produce a reproducible specific and sensitive analytical method in a cost effective manner. The parameters of validation involved are introduced as specificity, method precision, accuracy, linearity, limit of detection (LOD), limit of quantitation (LOQ), ruggedness, robustness and system precision of the target molecule.
Keywords: Method development, Method validation, Limit of detection, Limit of quantitation, Robustness, Ruggedness