A Validated High Performance Liquid Chromatography Method for the Simultaneous Analysis of Guaifenesin, Ambroxol and Loratidine in Bulk and Liquid Dosage form.

ABSTRACT

A simple and sensitive HPLC method for simultaneous quantification of guaifenesin, ambroxol and loratidine in bulk and liquid dosage form was developed and fully validated. The separation and quantification was performed using a Kromasil C8 (250 × 4.6 mm, particles 5 μm) HPLC column. Isocratic elution mode with a flow rate of 1.2 mL/min was used, and the injection volume was 10 μL. The detector was set to a wavelength of 290 nm and the column oven was maintained at 30 °C. Orthophosphoric acid (0.1%) and acetonitrile in the ratio of 6040 v/v was used as the mobile phase. Guaifenesin, ambroxol and loratidine were eluted with retention time of 3.045 min, 5.489 min and 13.981 min, respectively. The method was validated in accordance with ICH guidelines and the results of all the validation parameters were found to be within the acceptable limits. The calibration plots were linear over the concentration ranges from 50-150 μg/mL, 30-90 μg/mL and 5-15 μg/mL for guaifenesin, ambroxol and loratidine, respectively. Developed method was successfully applied for the quantification of the above three drugs in liquid dosage form. The excipient did not interfere with drug peaks.