Open AccessCleaning Method Validation for Estimation of Dipyridamole Residue on the Surface of Drug Product Manufacturing Equipment Using Swab Sampling and by High Performance Liquid Chromatographic Technique
Author(s) -
Sriram Valavala,
Nareshvarma Seelam,
T. Subbaiah,
Vivekanandan Sundaramurthy
Publication year - 2020
Publication title -
turkish journal of pharmaceutical sciences
Language(s) - English
Resource type - Journals
eISSN - 2148-6247
pISSN - 1304-530X
DOI - 10.4274/tjps.galenos.2019.70446
Subject(s) - chromatography , detection limit , dipyridamole , cartridge , phosphate buffered saline , chemistry , materials science , analytical chemistry (journal) , medicine , metallurgy , radiology
Cleaning validation is the procedure used to ensure that the cleaning process has eliminated the residues of drug substance from on the equipment surface after manufacture. A simple, sensitive, robust, and accurate high performance liquid chromatographic method was developed for the quantitative estimation of dipyridamole in swab samples obtained from the equipment surface after the manufacture of dipyridamole modified release capsules.