Stability Indicating UPLC Method for Determination of Related Substances in Doxazosin mesylate Sushma Bulusu Lakshmi1,2,*, Madhusudhan Gutta1, Jayashree Anireddy2 1Inogent Laboratories Pvt. Ltd., 28-A, IDA Nacharam, Hyderabad, 500 072, India 2Centre for Chemical Sciences and Technology, Institute of Science and Technology, Jawaharlal Nehru Technological University, Kukatpally, Hyderabad, 500 085, India *Corresponding Author E-mail: sushma.bulusu@gmail.com
Online published on 17 July, 2017. Abstract A simple, sensitive and stability representative UPLC technique has been developed for Doxazosin mesylate, its related substances and degradation impurities formed in forced degradation. The drug was undergone to stress conditions of oxidative, acid, base hydrolysis, photolysis and thermal degradation. Doxazosin mesylate was observed degradation under base hydrolysis and acid hydrolysis. Doxazosin mesylate is stable in remaining circumstances. Effective separation found from process impurities and degradation impurities in forced degradation was succeeded on a Acquity UPLC BEH C18 stationary phase using Aqueous 2% H3PO4 as eluent-A and eluent-B as combination of Methanol: Water: Acetonitrile (200: 100: 700) in a gradient mode. The analysis were carried out at 210 nm. The developed UPLC technique was certified with respect to precision, specificity, robustness, accuracy and linearity. This established technique be able to be used for analysis of routine and stability samples of Doxazosin mesylate. Top Keywords Degradation products, Doxazosin mesylate, Validation, Stress conditions, UPLC. Top |