Quantitation of Phenylephrine Hydrochloride in Pharmaceutical Dosage Forms

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Abstract
A reverse phase high-pressure liquid chromatography method for the quantitation of phenylephrine hydrochloride in a variety of pharmaceutical dosage forms has been developed. The developed method did not require the use of a counter-ion t o increase the retention time of phenylephrine. The method is simple, accurate, precise and reproducible with a percent relative standard deviation of 0.54 based on 6 injections. The results were in excellent agreement with the results obtained using a colorimetric method. The separation between phenylephrine, the internal standard and other ingredients is greatly affected by pH changes (between 5.9-6.1) and the particle size of the column materials (5 micron versus 10 micron). A number of other active ingradinents brompheniramine maleate, chlopheniramine maleate, phenylpropanolamine and guaifenesin, etc. and the excipients such as parabens and sodium benzoate did not interfere with the assay procedure.