Simultaneous determination of naphazoline hydrochloride and pheniramine maleate along with their related compounds by high performance liquid chromatography on an Alliance iS HPLC System

In this application note, Waters developed a liquid chromatographic method for simultaneous determination of two active ingredients - naphazoline hydrochloride and pheniramine maleate ophthalmic, along with their related compounds. The method achieved complete separation of analytes within 20 minutes, in a single run at a temperature of 40 °C and a flow rate of 2.0 mL min−1, using an XSelect™ CSH C18 Column. A comprehensive evaluation of system suitability, range, accuracy (recovery), intraday and interday precisions was performed as a part of this study. The method was also found to be linear in the range of 80 to 120% with respect to the API concentration in a working concentration, displaying a correlation coefficient (R2 ) greater than 0.997. As a practical application, the method was successfully used for the routine analysis of commercially available ophthalmic and nasal solutions, without significant interference from the excipients.