Development and validation of a HPLC method for simultaneous quantitative determination of adapalene and benzoyl peroxide in gel products

Abstract

Adapalene (AP) and Benzoyl peroxide (BO) have been used to treat acnes very efficient for many years, especially in gel products. But nowaday, that gel products still don't have in-house standard. And furthermore, the most difficult thing to build in-house standard is to assay simultaneously. The aim of this research is to build a method to assay two of AP and BO simultaneously by HPLC method. Subjects: AP (from India) and BO (from China). Solvents get the quality standard to use in liquid chromatography. Sample: gel product (AP 0.1% and BO 2.5%) prepared at Laboratory of School of Medicine, National University of HCMC. Chromatographic system: HPLC Shimadzu system with column C18 RP (250 x 4.6 mm; 5 mm), injection volumn 20 mL, detector at 270 nm, flow rate 1 mL/min, temperature 30oC, mobile phase with acetonitril - tetrahydrofuran - acid formic 0.1% in water 42 : 32 : 26. Validations: system suitability, specificity, linearity, accuracy, precision adapt to ICH. Results: The HPLC method for simultaneous quantitative determination of adapalene and benzoyl peroxide in gel products was built successfully. The method was achieved all validations term adapt to ICH: system suitability, specificity, linearity, accuracy, precision. Furthermore, that method is used to assay the concentration of two API (AP and BO) in the product (prepared at Laboratory of School of Medicine, National University of HCMC) with result: the concentration of AP is 101.38 0.87% and that of BO is 95.56 0.04 %, get the standard of USP 41.