International Journal of Pharmaceutical Chemistry and Analysis 2023;10(1):28–30 Content available at: https://www.ipinnovative.com/open-access-journals International Journal of Pharmaceutical Chemistry and Analysis Journal homepage: https://www.ijpca.org/ Review Article A review on specific and sensitive analytical method development and validation MD Nazmus Sakib Chowdhury 1, * 1 ACI Health Care Limited (US FDA Approved), Narayanganj, Dhaka, Bangladesh ARTICLE INFO Article history: Received 22-01-2023 Accepted 11-02-2023 Available online 01-04-2023 Keywords: Method development Method validation Limit of detection Limit of quantitation Robustness Ruggedness ABSTRACT 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. This is an Open Access (OA) journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms. For reprints contact: reprint@ipinnovative.com 1. Introduction Specific and sensitive analytical method development is the prerequisite of method validation. It involves analytical chemistry that deals with quantification and qualification of target molecules. 1 Specific and sensitive analytical method development is required for noncompendial method. Based on molecular nature and physiological properties of target molecule, critical quality attributes of the method selected. After the selection of analytical method, method validation conducted. Based on method validation report, analytical test procedure has updated. Specific and sensitive analytical method development is the continuous process of solving problems finding at any site of stage of product development. 2 The analytical chemistry and both quantification and qualification of target molecule * Corresponding author. E-mail address: nscphr@gmail.com (M. D. Nazmus Sakib Chowdhury). conducted based on current good manufacturing practices (cGMP) and USFDA (Food and drug administration, USA) regulations. 3 2. Discussion 2.1. Sensitive & specific analytical method development Analytical method development introduces a procedure for unknown compound identified and quantified from sample matrix. When no detection technique available in compendia, specific molecule method development needs to initiate based on molecular nature, pH, pKa and other physicochemical properties. Based on method development, method validation conducted for the target molecule. However, any problem finds at the time of routine use of that analytical method, method development initiates and revalidated. 4 https://doi.org/10.18231/j.ijpca.2023.005 2394-2789/© 2023 Innovative Publication, All rights reserved. 28