K.S.M.L. Sushmitha, Kumarswamy Ummiti, J.V. Shanmukha Kumar
K.S.M.L. Sushmitha, Kumarswamy Ummiti*, J.V. Shanmukha Kumar
Department of Chemistry, Koneru Lakshmaiah Education Foundation, Green Fields, Vaddeswaram, Guntur, Andhra Pradesh – 522502.
Volume - 14,
Issue - 11,
Year - 2021
Clobeatsol propionate foam is a topical class 1 corticosteroid used to treat itching and inflammatory arthritis on the skin occurred by allergic reactions, psoriasis and eczema. In the pharmaceutical aerosol products, Dehydrated alcohol (Ethanol) is the primary ingredient and its concentration level in the formulation composition plays a significant role in the regulation of aerosol rate, droplet shape and particle size. It can also act as solubilizer for active pharmaceutical ingredient, topical disinfectant and skin permeation enhancer. Hence accurate assay of Ethanol is a crucial quality control component. A simple and rapid gas chromatography method was developed to quantify Ethanol content in Clobetasol propionate foam drug product using fused silica glass tube non-polar capillary column (HP-5, 30 m, 0.53 mm, 1.5 µm). Ethanol in the sample was diluted with methanol after adding suitable amount of internal standard, the isopropyl alcohol solution.The developed method is precise, linear and accurate in the range of 5 mg/mL to 15 mg/mL of nominal concentration of ethanol i.e. 10 mg/mL . The presented method has an advantage of a very quick gas chromatographic separation (less than 16 min) and therefore is highly suitable for in-process and stability analysis of Ethanol content in Clobetasol propionate foam drug product.
Cite this article:
K.S.M.L. Sushmitha, Kumarswamy Ummiti, J.V. Shanmukha Kumar. A Rapid Method for the determination of Dehydrated alcohol (Ethanol) content in Clobetasol propionate foam by Non-polar Capillary Gas chromatography. Research Journal of Pharmacy and Technology. 2021; 14(11):5919-5. doi: 10.52711/0974-360X.2021.01029
K.S.M.L. Sushmitha, Kumarswamy Ummiti, J.V. Shanmukha Kumar. A Rapid Method for the determination of Dehydrated alcohol (Ethanol) content in Clobetasol propionate foam by Non-polar Capillary Gas chromatography. Research Journal of Pharmacy and Technology. 2021; 14(11):5919-5. doi: 10.52711/0974-360X.2021.01029 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-11-55
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