PREPARATION, VALIDATION, EFFICACY AND SAFETY ASSESSMENT OF TOPICAL ANTI-INFLAMMATORY FORMULATION Authors: D’souza MG , KASAR R, BORSE LB AND BYAHATTI VV
ABSTRACT
Inflammation is a biological defence mechanism, but chronic inflammation can contribute to conditions
such as arthritis and musculoskeletal disorders. This study focuses on the formulation, validation, and
evaluation of an anti-inflammatory formulation (ointment) containing glucosamine sulphate, methyl
salicylate, magnesium sulphate, clove oil and sodium chloride as active pharmaceutical ingredients.
The ointment was developed using a modified fusion method and assessed for physicochemical and
pharmacological efficacy. Among the three formulations; F1, F2, and F3, F2 exhibited optimal pH,
spreadability, viscosity and compatibility and demonstrated significant analgesic and anti-inflammatory
activity making it the most suitable for topical application. Stability studies confirmed that F2
maintained its efficacy over twelve months without significant degradation. UV-visible spectroscopy
analysis validated the presence of glucosamine sulfate and methyl salicylate at 210 nm and 270 nm,
respectively, while FTIR analysis confirmed the structural integrity and compatibility of the formulation
components. Skin sensitivity tests revealed no redness, irritation or adverse reactions. These findings
indicate that F2 is a promising, stable, and effective anti-inflammatory ointment formulation.
Keywords: Anti-inflammatory, Ointment, Glucosamine Sulfate, Methyl salicylate, Magnesium
sulphate, Clove oil, Validation Publication date: 01/05/2026 https://www.ijbpas.com/pdf/2026/May/MS_IJBPAS_2026_10096.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2026/15.5.10096