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Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF GLYCERIN CONTENT IN TOPICAL MOISTURIZING GEL OTC FORMULATION BY GAS CHROMATOGRAPHY

Subhash Kale*, Sumanth Prabhu and Dr. A. Venkatachalam

ABSTRACT

Glycerin is widely used in topical treatment of skin and also during oral treatment for dry mouth. Glycerin basically acts as a humectant8 that means substance that aids in reduction in loss of moisture from skin or from wound. Many types of formulations available in the market that contains Glycerin as principal component mainly used to retain moisture within the skin. Glycerin has many medicinal benefits and it acts as Cleanser, Toner, Moisturizer, treatment of Acne, Dry Skin, and Wrinkles, Skin lightning, treating cracked heels, Scar removal, and can also be used as sunscreen. In sunscreen moisturizing gels, Glycerin is used as main active ingredient with 20% w/w concentration. Estimation of Glycerin in such gel type of topical dosage forms is important as a part of formulation batch release and during stability study. The purpose of the present study was to develop accurate and precise analytical method for determination of Glycerin in topical moisturizing gel by gas chromatography. An internal standard technique is proposed in order to reduce sample preparation and injection related errors thereby improving method accuracy. 2,2,2- Trichloroethanol chemical compound is used as an internal standard purpose while Isopropyl alcohol is used as diluent for standard and sample preparations. Further developed method was validated as per ICH guidelines to prove its suitability for intended purpose.

Keywords: Glycerin, 2,2,2- Trichloroethanol, Isopropyl alcohol, Gas Chromatography, Internal standard, Humectant, Method validation, Topical moisturizing gel, OTC (Over the counter).


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