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.
Highlights
Sodium cromoglycate (SCG) is 5,5′-(2-hydroxypropane-1,3-diyl)bis(oxy)bis(4-oxo-4H-chromene-2-carboxylic acid) disodium salt (Fig. 1a)
Several methods have been reported for the determination of sodium cromoglycate (SCG) in pharmaceutical preparations such as spectrophotometry [3, 4], electrophoresis [5], electrochemical [6, 7] and HPLC methods. [8,9,10,11,12,13,14] Oxymetazoline hydrochloride (OXMT) has been analyzed by several methods in pharmaceutical preparations such as spectrophotometry [3, 15,16,17,18,19,20,21,22,23], capillary electrophoresis [24, 25], gas chromatography [26, 27] and HPLC. [28,29,30,31,32,33,34,35] Abdel-Aziz et al [3] developed new accurate, sensitive and selective spectrophotometric and spectrofluorimetric methods for determination of SCG and OXMT
Rf values were found to be 0.1±0.01 and 0.3±0.01 for SCG and OXMT, respectively as shown in (Fig. 2). This separation allows the determination of SCG and OXMT at 235 nm without any interference from each other
Summary
Sodium cromoglycate (SCG) is 5,5′-(2-hydroxypropane-1,3-diyl)bis(oxy)bis(4-oxo-4H-chromene-2-carboxylic acid) disodium salt (Fig. 1a). It exerts its action via preventing the release of mediators that would normally attract inflammatory cells. Several methods have been reported for the determination of SCG in pharmaceutical preparations such as spectrophotometry [3, 4], electrophoresis [5], electrochemical [6, 7] and HPLC methods. The aim of this work is to develop simple chromatographic methods for the simultaneous determination of SCG and OXMT in pharmaceutical dosage form
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