A RP-HPLC Method for Simultaneous Estimation of Ambroxol Hydrochloride and Loratidine in Pharmaceutical Formulation

A simple, selective, rapid, precise and economical reverse phase HPLC method has been developed for the simultaneous estimation of Ambroxol Hydrochloride and Loratidine from pharmaceutical dosage forms. The method was carried out on a Phenomenex Gemini C₁₈ (25 cm x 4.6 mm i.d., 5 μ) column with a mobile phase consisting of acetonitrile: 50mM Ammonium Acetate (50:50 v/v) at a flow rate of 1.0 mL/min. Detection was carried out at 255 nm. Hydrochlorthiazide was used as an internal standard. The retention time of Ambroxol Hydrochloride, Loratidine and Hydrochlorthiazide was 5.419, 15.549 and 3.202 min, respectively. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantitation and solution stability. The proposed method can be used for the estimation of these drugs in combined Pharmaceutical dosage forms.