Work

Method Development and Validation for the Simultaneous Analysis of Miconazole Nitrate, Hydrocortisone and Chlorocresol in a Pharmaceutical Topical Cream by Reverse Phase Liquid Chromatography

Year: 2026

Type: article

Abstract: Miconazole/Hydrocortisone (HCA) cream is a pharmaceutical formulation developed as a combination of three major components (HCA, miconazole nitrate [MCN] and chlorocresol [CHL]). In some instances, reference monographs used for referencing the quantification of pharmaceutical molecules focus on individual analysis of molecules. Therefore, there is need to develop, optimize and validate methods that simultaneously separate constituents of a combined formulation. In this study, a method for the separation of HCA, MCN and CHL in miconazole/HCA cream was developed by investigating the effect of mobile phase, stationary phase, wavelength and gradient program on the separation of HCA, MCN and CHL in miconazole/HCA cream. A 10 mM ammonium acetate (AAC) buffer pH 5.0 was used. Acetonitrile was used as the organic modifier. An injection volume of 10 µL was used on a C18, 15 cm × 4.6 mm Zorbax. The optimum conditions for reverse phase liquid chromatography were obtained as follows: injection volume (10 µL), column temperature (30°C), flow rate (1 mL/min), gradient elution program: 0 min, 60AAC:40ACN; 4 min, 60AAC:40ACN; 9 min, 5AAC:95ACN; 13 min, 5AAC:95ACN using a C18 stationary phase, UV detector, 5 µm stationary phase pore size and post run of 3 min.

Source: Analytical Science Advances

DOI: 10.1002/ansa.70085

Authors: Netai Mukaratirwa‐Muchanyereyi, Pretty Chihiya, Stephen Nyoni

Institutions: Bindura University of Science Education, Chinhoyi University of Technology

Language: English

Topic: Analytical Methods in Pharmaceuticals

Subfield: Analytical Chemistry

Field: Chemistry

Domain: Physical Sciences

Open Access status: gold

Estimated APC paid: $3,180

Funder: Bindura University of Science Education