.
.
Marothu VK, Yerramothu P, Gorrepati M, Majeti S, Mamidala SK, Nellutla A.
.
Ann Pharm Fr. 2015 Nov;73(6):442-51. doi: 10.1016/j.pharma.2015.05.001. Epub 2015 Jul 2.
Abstract
In the present study, the compatibility between bisoprolol fumarate and selected excipients (ascorbic acid, citric acid anhydrous, butylated hydroxyanisole, polyvinylpyrrolidone, glycerol, mannitol and sorbitol) in mixtures (1:10 ratio of drug and excipient) was investigated by subjecting the samples to isothermal stress conditions (90 °C for 48 h). A new HPLC method was developed, validated and employed for determining the drug content of the stressed compatibility samples. Results of HPLC revealed that major degradation of bisoprolol fumarate was observed with butylated hydroxyanisole (89.4%), citric acid anhydrous (89%), mannitol (77%) and glycerol (61.9%). CI – Copyright © 2015. Published by Elsevier Masson SAS.
Keywords: .
Link/DOI: 10.1016/j.pharma.2015.05.001