Simultaneous Determination of Cromolyn Sodium Combined Dosage Forms Using Isocratic HPLC Method

Abstract

A simple and selective reversed-phase high-performance liquid chromatography method was developed for the estimation of cromolyn sodium (CRM) with either oxymetazoline hydrochloride (OMZ) or xylometazoline hydrochloride (XMZ) in their binary mixtures. The method is based on the simultaneous separation of each drug in a reversed-phase Waters symmetry^® C18 column (250 mm × 4.6 mm intradermally, 5-µm particle size) at 25°C. Elution was performed with a mobile phase consisting of methanol : 0.1 M phosphate buffer (60:40, v/v, pH 4.0). Quantitation was achieved with ultraviolet detection at 220 nm. The method could determine the three drugs, with linearity, in the range of 2.0-100.0 µg/mL for CRM and 0.8-8.0 µg/mL for OMZ and for XMZ. Aspirin was used as internal standard. Optimization of the separation in terms of mobile phase composition is critical to the method development, which is discussed in detail. The suggested procedure was successfully applied to the analysis of the studied drugs in their nasal preparations. Statistical evaluation of the data obtained by the proposed and comparison methods revealed good accuracy of the proposed method.