A chromatographic method for rapid and simultaneous analysis of codeine phosphate, ephedrine HCl and chlorpheniramine maleate in cough-cold syrup formulation.

The present paper describes a simple, accurate and precise reversed phase HPLC method for rapid and simultaneous quantification of codeine phosphate, ephedrine HCl and chlorpheniramine maleate in a cough-cold syrup formulation. Separations were carried out on a Zorbax XDB C8 column (150 x 4.6 mm ID), 5 microm particle size. A gradient elution system was developed using varying percentages of two mobile phases: methanol-glacial acetic acid-triethylamine (980:15:6 v/v) and water-glacial acetic acid-triethylamine (980:15:6 v/v). The elution of the analytes was achieved in less than 7 min with a flow rate of 1.5 ml/min. Detection was by UV absorbance at a wavelength of 254 nm. Quantification of the components in actual syrup formulations was calculated against the responses of freshly prepared external standard solutions. The method was validated and met all analysis requirements of quality assurance and quality control recommended by FDA of the USA.