Development and Validation of Analytical Methods for Simultaneous Estimation of Some Drugs in Pharmaceutical Dosage Form

Abstract

For the simultaneous measurement of Fexofenadine hydrochloride (FEXO) and Montelukast sodium (MONTE) in combined tablet formulation, a new reversed-phase high performance liquid chromatography method was developed. Using 0.05 percent Orthophosphoric acid with a PH of 2.5 and a flow rate of 1 ml/min, efficient separation was obtained using a C18 Grace Column (4.6 250 mm, 5 um) as stationary phase with Methanol and H2O (70:30, v/v) as mobile phase.At 241.0 nm, the UV 730 D PDA detector was used for detection. Fexofenadine and Montelukast have a retention time of 6.0167 min and 8.500 min, respectively. The FEXO and MONTE were found to be linear throughout a range of60 \(\mu\)g/mL to 300 \(\mu\)g/mL and 5 \(\mu\)g/mL to 25 \(\mu\)g/mL , respectively. The developed method was precise, accurate, economic, quick, and selective. For drugs, the approach provides good resolution.FEXO & MONTE were separated using the aforesaid method with good peaks, minimal tailing, good retention time, and appropriate resolution time between peaks. As a result, this procedure was found to be appropriate and finalised.