Simultaneous determination of pseudoephdrine, pheniramine, guaifenisin, pyrilamine, chlorpheniramine and dextromethorphan in cough and cold medicines by high performance liquid chromatography.
A new simple, rapid and sensitive liquid chromatographic method has been developed and validated for the simultaneous determination of pseudoephdrine, pheniramine, guaifenisin, pyrilamine, chlorpheniramine and dextromethorphan in cough and cold pharmaceuticals. The separation of these compounds was achieved within 13 min on a Kromasil C18 column using an isocratic mobile phase consisting of methanol-dihydrogenphosphate buffer at pH 3 (45:55, v/v). The analysis was performed at a flow rate of 1 mL min(-1) and at a detection wavelength of 220 nm. The selectivity, linearity of calibration, accuracy, within and between-days precision and recovery were examined as parts of the method validation. The concentration-response relationship was linear over a concentration range of 5-50 microg mL(-1) for pseudoephdrine, pheniramine, chlorpheniramine and 50-600 microg mL(-1) for guaifenisin, pyrilamine, dextromethorphan, methylparaben and sodium benzoate with correlation coefficients better than 0.998. The standard deviations of the intraday and interday were all less than 2%. The proposed liquid chromatographic method was successfully applied for the routine analysis of these compounds in different cough and cold pharmaceutical preparations such as syrups, capsules, tablets and sachets. The presence of preservatives (sodium benzoate and methylparaben) and other excipients did not show any significant interference on the determination of these compounds.
Louhaichi
M R
MR
Laboratoire National de Contrôle des Médicaments, 11 bis Rue Jebel Lakhdar Bab Saadoun, 1006 Tunis, Tunisie.
Jebali
S
S
Loueslati
M H
MH
Adhoum
N
N
Monser
L
L
D000996:Antitussive Agents / Q000032:analysis*; D002138:Calibration; D002744:Chlorpheniramine / Q000032:analysis; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003915:Dextromethorphan / Q000032:analysis; D005100:Expectorants / Q000032:analysis*; D006140:Guaifenesin / Q000032:analysis; D004364:Pharmaceutical Preparations / Q000032:analysis; D010632:Pheniramine / Q000032:analysis; D054199:Pseudoephedrine / Q000032:analysis; D011738:Pyrilamine / Q000032:analysis; D015203:Reproducibility of Results
D000996:Antitussive Agents; D005100:Expectorants; D004364:Pharmaceutical Preparations; D010632:Pheniramine; D002744:Chlorpheniramine; D006140:Guaifenesin; D003915:Dextromethorphan; D054199:Pseudoephedrine; D011738:Pyrilamine