HPLC determination of guaifenesin with selected medications on underivatized silica with an aqueous-organic mobile phase

• Published in: Journal of pharmaceutical and biomedical analysis Vol. 23; no. 5; pp. 909 - 916
• Main Authors: Wilcox, Meredith L, Stewart, J.T
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier B.V 01.10.2000; Elsevier Science
• Subjects: Analysis; Antitussive Agents - analysis; Biological and medical sciences; Bronchodilator Agents - analysis; Capsules; Chromatography, High Pressure Liquid; Codeine; Codeine - analysis; Dextromethorphan; Dextromethorphan - analysis; Drug Combinations; Ephedrine - analysis; Expectorants - analysis; General pharmacology; Guaifenesin; Guaifenesin - analysis; HPLC; Indicators and Reagents; Medical sciences; Pharmacology. Drug treatments; Pseudoephedrine; Reference Standards; Reproducibility of Results; Silica; Silicon Dioxide; Solutions; Pseudoephedrine; Dextromethorphan; Silica; Guaifenesin; HPLC; Codeine; Morphinan derivatives; Validation; HPLC chromatography; Opiates; Capsule; Syrup; Expectorant; Mucolytic; Ultraviolet detector; Dosage form; Quantitative analysis
• ISSN: 0731-7085; 1873-264X
• DOI: 10.1016/S0731-7085(00)00359-9

A high performance liquid chromatography procedure has been developed for the simultaneous determination of guaifenesin–pseudoephedrine–dextromethorphan and guaifenesin–pseudoephedrine in commercially available capsule dosage forms and guaifenesin-codeine in a commercial cough syrup dosage form. The separation and quantitation are achieved on a 25-cm underivatized silica column using a mobile phase of 60:40% v/v 6.25 mM phosphate buffer, pH 3.0 — acetonitrile at a flow rate of 1 ml min −1 with detection of all analytes at 216 nm. The separation is achieved within 10 min for each drug mixture. The method showed linearity for the guaifenesin–pseudoephedrine–dextromethorphan mixture in the 50–200, 7.5–30 and 2.5–10 μg ml −1 ranges, respectively. The intra- and inter-day RSDs ranged from 0.23 to 4.20%, 0.18 to 2.85%, and 0.13 to 5.04% for guaifenesin, pseudoephedrine, and dextromethorphan, respectively. The guaifenesin–pseudoephedrine mixture yielded linear ranges of 25–100 and 3.75–15 μg ml −1 and intra- and inter-day RSDs ranged from 0.65 to 4.18% and 0.23 to 3.00% for guaifenesin and pseudoephedrine, respectively. The method showed linearity for the guaifenesin–codeine mixture in the 25–100 and 2.5–10 μg ml −1 ranges and RSDs ranged from 0.37 to 4.25% and 0.14 to 2.08% for guaifenesin and codeine, respectively.