Comparative study of two different chromatographic approaches for quantitation of hydrocortisone acetate and pramoxine hydrochloride in presence of their impurities

Abstract

In the present study, we compare the performance of two reversed-phase liquid chromatographic approaches using different eluents either conventional hydro-organic eluent or micellar one for simultaneous estimation of hydrocortisone acetate and pramoxine hydrochloride in presence of their degradants and process-related impurities; hydrocortisone and 4-butoxyphenol, respectively. For conventional reversed-phase liquid chromatography (RPLC), separation of the studied compounds was completed on an Inertsil ODS 3-C18 column (150 mm × 4.6 mm, 5 μm particle size) with a mobile phase consists of 50 mM phosphate buffer (pH 5.0): acetonitrile (50: 50, v/v). For micellar liquid chromatography (MLC), an Eclipse XDB-C8 column (150 mm × 4.6 mm, 5 μm particle size) was chosen for the separation with a green mobile phase consists of 0.15 M sodium dodecyl sulfate, 0.3% triethylamine and 10% n-butanol in 20 mM orthophosphoric acid (pH 5.0). Both methods were extended to analyze hydrocortisone acetate and pramoxine hydrochloride in their co-formulated cream. RPLC was superior to MLC with regard to sensitivity for the estimation of impurities. While, MLC represents an eco-friendly, less hazardous and biodegradable approach. Furthermore, the direct injection of the cream to the system without the need to laborious samples pretreatment, excessive amount of analysis time and/or use of large amount of toxic organic solvents is one of the outstanding advantages of MLC.

Validated thin‐layer chromatography method for simultaneous determination of sulfacetamide sodium and hydrocortisone acetate in the ophthalmic formulation

“…A thorough literature search revealed only one quantitative analytical spectroscopic method was published for this combination [11]. In addition to this approach, other HPLC [10–27], TLC/high‐performance TLC [28–32], UV spectroscopy [8–40], and potentiometric [7–43] methods have been reported for the analysis of individual components from the combination under study. We thought it would be interesting to develop and validate a sensitive, precise, accurate, and reliable TLC method to simultaneously quantify SUL and HCA in bulk and pharmaceutical dosage forms.…”

Experimental substantiation of the composition of the gel base with hydrocortisone for use in veterinary medicine

“…Prednisolone, methylprednisolone, dexamethasone and hydrocortisone are most commonly prescribed [6,7].…”

Analytical method development and determination of hydrocortisone acetate and fusidic acid simultaneously in cream formulation, by reversed‐phase HPLC

“…It has both mineralocorticoid and to a greater extent glucocorticoid activity. Hydrocortisone acetate is a potential impurity of hydrocortisone, chemically designated as 11 β ,17,21‐trihydroxypregn‐4‐ene‐3,20‐dione (BP, 2019; USP, 2018), and formulated in different medicinal dosage forms in pharmaceuticals with good glucocorticoid activity (Ibrahim, El‐Deen, & Shimizu, 2018). Hydrocortisone acetate is used for the treatment of skin disorders, such as allergies, dermatitis, eczema and rashes, by being absorbed into the skin and minimizing inflammation, redness or itching, which are common in these types of conditions (Adi‐Dako, Oppong Bekoe, Ofori‐Kwakye, Appiah, & Peprah, 2017).…”