A New Green Analytical RP-HPLC Method Development and Validation for Simultaneous Estimation of Bromhexine and Cephalexin

A new green isocratic RP-HPLC method was developed and validated for simultaneous quantification of the Bromhexine and Cephalexin content in tablet formulation, by using relatively eco-friendly – methanol as an organic solvent in the mobile phase. Waters C-18 (250 mm x 4.6 mm, 5 μm) column was used. At room temperature and a flow rate of 1ml/min, the optimized mobile phase was a mixture of Methanol: Ammonium acetate buffer 70:30 (v/v) at a pH of 5.1. The UV detector was set at 228 nm for Bromhexine and Cephalexin determination. The linearity range was 0.2-2 µg/ml and 12.5-125 µg/ml for bromhexine and Cephalexin respectively. The retention times were 3.6 min for bromhexine and 6.2 min for Cephalexin. Undertaken the studies of forced degradation in order to realize the stability indicating the nature of the proposed method. As per the current ICH guides (Q2R1), validation of the method was conducted.