Spectral resolution and simultaneous determination of oxymetazoline hydrochloride and sodium cromoglycate by derivative and ratio-based spectrophotometric methods

Abstract

Sodium cromoglycate (SCG) and oxymetazoline hydrochloride (OXMT) are administered in combination for effective treatment of nasal congestion and allergy. In this work, SCG was determined using direct spectrophotometry by measuring its zero order absorption spectra at its λ_max 320.6 nm where OXMT showed zero absorbance. On the other hand, four simple, sensitive and precise spectrophotometric methods were developed and validated for the determination of OXMT in the presence of SCG in their laboratory prepared mixtures and pharmaceutical formulation, without preliminary separation; Method A: first derivative spectrophotometric method [¹D], Method B: first derivative of ratio spectra method [¹DD], Method C: ratio difference spectrophotometric method [RDSM] and Method D: ratio subtraction method [RSM]. Ratio manipulating methods (Method B, C and D) were done using divisor of 10.00 µg/mL SCG. Linear correlation was obtained in range 4-22 µg/mL for OXMT by methods A, B and D and 6-22 µg/mL for method C. All methods were validated in compliance with the International Conference on Harmonization (ICH) guidelines and satisfactory results were obtained. No significant difference was noted between the developed methods and the official one with respect to accuracy and precision.