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Chemical Stability of Brompheniramine Maleate in an Oral Liquid Dosage Form

Author(s):  Gupta Vishnu D, Gupta Vikas S

Issue:  Jan/Feb 2011 - Volume 15, Number 1
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Abstract:  The chemical stability of brompheniramine maleate in an oral liquid dosage form was studied by using a stability-indicating high-performance liquid chromatographic assay method that was developed in the University of Houston (Houston, Texas) laboratory. The concentrations of the drug were directly related to peak heights, with an R value of 0.999. The percent relative standard deviation based on five injections was 1.0. The products of decomposition and the excipients present in the dosage forms did not interfere with the developed assay method. The formulation was stable for at least 202 days when stored in amber-colored glass bottles at room temperature. The pH value of the formulation remained constant at 2.7 after 202 days of storage, and the physical appearance of the formulation did not change.

Related Keywords: Vishnu D. Gupta, PhD, Vikas S. Gupta, brompheniramine maleate, antihistamine, stability, stability-indicating assay


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