Compatibility of atenolol with excipients: LC-MS/TOF characterization of degradation/interaction products, and mechanisms of their formation.

Abstract:

:A study was carried out to investigate compatibility of atenolol, a beta(1) blocker, with a variety of pharmaceutical excipients. The binary mixtures (1:1) of atenolol with the excipients were stored for 1 month at 40 degrees C/75% RH. The samples were directly observed for the physical changes, and also analyzed by a validated HPLC method to determine the chemical changes. The study revealed that atenolol was incompatible with ascorbic acid, citric acid and butylated hydroxyanisole. The degradation/interaction products formed in these mixtures were characterized by high resolution mass spectrometric and fragmentation analyses, using a LC-MS/TOF system. The identity of characterized structures was justified through mechanistic explanations.

journal_name

J Pharm Biomed Anal

authors

Kumar V,Shah RP,Malik S,Singh S

doi

10.1016/j.jpba.2009.01.014

subject

Has Abstract

pub_date

2009-05-01 00:00:00

pages

880-8

issue

4

eissn

0731-7085

issn

1873-264X

pii

S0731-7085(09)00039-9

journal_volume

49

pub_type

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