DOMINATED RP-HPLC METHOD FOR QUALITY CONTROL OF TERNARY PHARMACEUTICAL FORMULATION: GUAIFENESIN/LEVOCETIRIZINE/ AMBROXOL HCL AND STABILITY STUDIES

The present investigation was aimed to establish a liquid chromatographic method for simultaneous quantification of guaifenesin, levocetirizine and ambroxol HCl in ternary fixed dosage form. The three drugs were swiftly resolved using ODS C18 reverse phase column with mobile phase consisting of ammonium phosphate buffer, pH 4.5: acetonitrile (60:40, v/v) at a flow rate of 1.0 mL/min and UV detection at 236 nm. The retention time values were 2.231, 2.772 and 6.309 min, respectively, for guaifenesin, levocetirizine and ambroxol HCl. The response was a linear function of analyte over the concentration range of 12.5-75 µg/mL, 0.625-3.750 µg/mL and 3.75-22.5 µg/mL with correlation co-efficient value of 0.999. Maximum recovery (99.12-101.2 %) was obtained in ternary liquid oral formulation (Leoriv plus syrup). Three drugs were well resolved from their degradation products and net degradation was calculated in acid hydrolysis, base hydrolysis, oxidation, thermal and UV conditions. The proposed method enables the simultaneous quantification of guaifenesin, levocetirizine and ambroxol HCl in routine QC laboratories.