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Abstract

Topical creams that contain multicomponent active ingredients with antifungal, antibacterial and anti-inflammatory activities are designed to treat skin infections caused by bacteria and fungi and also to inhibit inflammation produced from such infections. Amongst these agents are betamethasone proprionate, clotrimazole and neomycin sulfate, often used in topical fixed-dose-combination formulations. These drugs are best assayed by HPLC, which is not easily accessed. Three brands of creams marked - I, II and III containing betamethasone diproprionate, clotrimazole and neomycin sulfate as actives were evaluated. Clotrimazole and betamethasone were extracted from cream in basic medium using DCM. Residual neomycin sulfate in basic medium was quantified by deamination using ninhydrin reagent at 570 nm, while amount of clotrimazole and betamethasone in DCM were determined by simultaneous UV spectrophotometry at 240 nm and 300 nm. The amount of CTZ, BMS and NEO in creams ranged from 96.67±0.98 to 100.33±1.69 %, 94.67±1.99 to 98.00±1.67 and 97.60±1.67 (t = 1.624) to 99.67±0.84 respectively. Method validation showed linearity for BMS, CTZ and NEO for concentrations ranging from 2 - 50 µg mL-1 (R2 ? 0.9996). The slopes and intercepts of the regression equations were ? 0.0981 and ? -0.068 respectively, while calculated standard errors were ? 0.25. The Limits of detection (LOD) and quantification (LOQ) for all brands ranged from 0.99 to 3.49 and 3.2 to 11.21 ?g/mL-1respectively. The percentage recovery for BMS, CTZ and NEO in two brands ranged from 91.50±1.13 to 101.50±0.36%. Statistically, brands were adjudged to have no significant difference from amount of drugs stated on the label at 95% confidence level as the student’s t-test values were found satisfactory.

Keywords

Fixed-dose-combination, Topical cream, Betamethasone, Clotrimazole, Neomycin

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Edebi N. Vaikosen
Corresponding author

Department of Pharmaceutical and Medicinal Chemistry, Faculty of Pharmacy, Niger Delta University, Wilberforce Island, Nigeria.

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Ruth C. Worlu
Co-author

Department of Pharmaceutical and Medicinal Chemistry, Faculty of Pharmacy, Niger Delta University, Wilberforce Island, Nigeria.

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Samuel J. Bunu
Co-author

Department of Pharmaceutical and Medicinal Chemistry, Faculty of Pharmacy, Niger Delta University, Wilberforce Island, Nigeria.

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Ebiere Dode
Co-author

Department of Pharmaceutical and Medicinal Chemistry, Faculty of Pharmacy, Niger Delta University, Wilberforce Island, Nigeria.

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Mary Doctor
Co-author

Department of Pharmaceutical and Medicinal Chemistry, Faculty of Pharmacy, Niger Delta University, Wilberforce Island, Nigeria.

Edebi N. Vaikosen*, Ruth C. Worlu, Samuel J. Bunu, Ebiere Dode, Mary Doctor, Liquid-Liquid Separation And Determination Of Betamethasone, Clotrimazole And Neomycin In Topical Cream By UV-Visible Spectrophotometry, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 4, 170-179. https://doi.org/10.5281/zenodo.8114461

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