Validated Chromatographic Methods for the Simultaneous Determination of Sodium Cromoglycate and Oxymetazoline Hydrochloride in a Combined Dosage Form

Abstract

Two chromatographic methods were developed and validated for the simultaneous determination of Sodium Cromoglycate (SCG) and Oxymetazoline Hydrochloride (OXMT). SCG and OXMT are administered in combination for effective treatment of nasal congestion and allergy. The first chromatographic method was based on usingaluminum TLC plates pre-coated with silica gel GF₂₅₄ as the stationary phase and chloroform: methanol: toluene: triethylamine (5: 2: 4:1, by volume) as the mobile phase followed by densitometric measurement of the separated bands at 235 nm. The second method is a high performance liquid chromatographic method for separation and determination of SCG and OXMT using reversed phase C₁₈ column with isocratic elution. The mobile phase composed of acetonitrile: methanol (2: 1, v/v) at flow rate of 1.0 mL/ min. Quantitation was achieved with UV detection at 220 nm. The validity of the proposed methods was assessed using the standard addition technique. The obtained results were statistically compared with those obtained by the official methods, showing no significant difference with respect to accuracy and precision at p = 0.05.