Simultaneous determination of pseudoephedrine hydrochloride, chlorpheniramine maleate, and dextromethorphan hydrobromide by second-derivative photodiode array spectroscopy.
The simultaneous determination of the active ingredients in multicomponent pharmaceutical products normally requires the use of a separation technique, such as HPLC or GC, followed by quantitation. Presented here is a rapid, validated, analytical method that does not require prior separation for the simultaneous determination of three drugs, pseudoephedrine hydrochloride, chlorpheniramine maleate, and dextromethorphan hydrobromide, in a tablet formulation. A diode array spectrophotometer, capable of multicomponent analysis, was used for the quantitation. The utility of this method was demonstrated in two ways: the analysis of a chewable pediatric tablet (formulation CP) containing 7.5 mg of pseudoephedrine hydrochloride, 0.5 mg of chlorpheniramine maleate, and 2.5 mg of dextromethorphan hydrobromide, and the dissolution analysis of a hydroxypropyl methylcellulose-based sustained-release tablet (formulation SR) containing 120 mg of pseudoephedrine hydrochloride, 8 mg of chlorpheniramine maleate, and 60 mg of dextromethorphan hydrobromide. The sensitivity of this assay is 7.5 micrograms/mL for pseudoephedrine hydrochloride, 1.0 micrograms/mL for chlorpheniramine maleate, and 5.0 micrograms/mL for dextromethorphan hydrobromide, using the second-derivative spectra of the absorbance with respect to wavelength. Determinations were made in 0.1 M sodium acetate buffer at pH 5.0 using a 1-cm quartz cell. Absorbance spectra, and their first and second derivatives, from 240 to 300 nm were used for the determination. The results obtained by this method compared favorably with the results obtained by a validated HPLC method.
Murtha
J L
JL
Research and Development, McNeil Consumer Products Company, Fort Washington, PA 19034.
Julian
T N
TN
Radebaugh
G W
GW
D002744:Chlorpheniramine / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D003692:Delayed-Action Preparations; D003915:Dextromethorphan / Q000032:analysis*; D004809:Ephedrine / Q000032:analysis*; D065347:Hypromellose Derivatives; D007981:Levorphanol / Q000031:analogs & derivatives*; D008747:Methylcellulose / Q000031:analogs & derivatives; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets
D003692:Delayed-Action Preparations; D013607:Tablets; D007981:Levorphanol; D065347:Hypromellose Derivatives; D002744:Chlorpheniramine; D003915:Dextromethorphan; D008747:Methylcellulose; D004809:Ephedrine