Abstract
A Reagent [3-hydroxyl 4- (1-azo-2,7-dihydroxyl) naphthalene Sulfonic acid] (AAN) ] has been synthesized for the determination of flourometholone (FLU) in pure form and in ophthalmic suspensions (drops) by a simple, sensitive and extraction-free spectrophotometric method. The method is based on the formation of yellow colored complex between FLU and ANN maximum at 416 nm. The stoichiometry of the complex in either form was found to be (1:1). Reaction conditions were optimized to obtain the maximum color intensity. Beer’s law was obeyed in the concentration ranges of 0.5-17.0 μg/mL. The limit of quantification (LOQ) was 0.14 μg/mL and molar absorptivity (AE) values was 38555 L/ moL-1cm-1. The proposed method has been applied successfully to the analysis of FLU in pure form and in its dosage forms and no interference was observed from common excipients present in pharmaceutical formulations. Statistical comparison of the results with the reference method showed excellent agreement and indicated no significant difference in accuracy and precision.
Highlights
Flourometholone (FLU) Systematic name is 9-Fluoro-11β, 17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione (Figure 1)
Flourometholone is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe [1]
The different analytical methods that have been reported for its determination include HPLC [2], with UV by using 1,4-Dihydrazinophthalazine as reagent [3], derivative spectrophotometry and HPLC [4], UV spectrophotometric by using methanol and sulfonic acid Buffer pH=3 [5], HPTLC [6]
Summary
Flourometholone (FLU) Systematic name is 9-Fluoro-11β, 17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione (Figure 1). The different analytical methods that have been reported for its determination include HPLC [2], with UV by using 1,4-Dihydrazinophthalazine as reagent [3], derivative spectrophotometry and HPLC [4], UV spectrophotometric by using methanol and sulfonic acid Buffer pH=3 [5], HPTLC [6]. The aim of this work is to synthesis organic reagents and used it in spectroscopic analytical study for the determination of Flourometholone (FLU) through complexion with new complex dye [3- hydroxyl 4-(1- azo -2, 7- hydroxyl) naphthalene Sulfonic acid] (AAN) (Figure 2) in dichloromethane medium has been applied, either in laboratory samples or in dosage forms, without any interference from the excipients that are normally present in formulations
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