Development and validation of stability-indicating RP-HPLC method for the simultaneous estimation of xylometazoline hydrochloride and ipratropium bromide from nasal spray dosage form

Abstract Background A simple, robust, precise, and an accurate HPLC method was established for simultaneous estimation of xylometazoline hydrochloride ipratropium bromide from a nasal spray dosage form. The effective separation obtained by injecting 10 μl sample standard solutions on to Inertsil ODS column, 250 × 4.6, mm, 5 μ at 45 °C using phosphate buffer with 1-pentane sulphonic acid sodium salt pH 4.7 as mobile phase acetonitrile the B. gradient optimized flow rate 1 mL/min wavelength 210.0 nm. Result complete analytical validation successfully carried out per ICH guidelines. retrieval study 50% 150% level working concentration, results were in range 99 101% both analytes. linearity proven 4 concentration linear regression curve ( R 2 =0.999) developed robust different parameters like column temperature, rate, pH, composition, gradient. Conclusion can be used form release test QC department manufacturing units.