ABSTRACT
A specific stability-indicating reversed-phase high-performance liquid chromatographic method was developed and validated for the estimation of meclizine hydrochloride (MEC) in tablet dosage form. The HPLC method has shown adequate separation of MEC from their degradation products. The separation was achieved on a C8 (250 mm×4.6 mm×5 µm) column using a mobile phase composition of 0.2% triethylamine in water and methanol in the ratio of 65:35(pH adjusted to 3.0 with orthophosphoric acid) with a flow rate of 1 mL/min. The wavelength of a photo-diode array detector was kept at 229 nm. Stress studies were performed initially under milder conditions followed by stronger conditions so as to get sufficient degradation around 5-20%. There were six degradation products observed with adequate separation from the analyte peak. Among those detected degradation products, structures of four degradation products were verified by comparison with known impurities of meclizine analogs. The method was validated as per the International Conference on Harmonization (Q2) guidelines. The method was specific, selective, accurate and precise to quantify meclizine in the presence of degradation products.
