Validation of a simple hplc method for the determination of chlorhexidine digluconate in solution

Abstract

Chlorhexidine Digluconate (CDG) is an antiseptic of biguadines class widely used as skin disinfectant. A high performance liquid chromatography method has been developed and validated for a rapid determination of CDG in commercial product (Kuratop®, 1%) and raw material. The method proved to be fast, specific, linear, precise, exact and robust for quantifying CDG in commercial product and raw material. Furthermore, the method was applied to quantification of CDG in the product filled in two different packings and submitted to accelerated (up to 6 months) and long-term (up to 1 year) stability studies. Throughout the period evaluated CDG content remained between 9.04 and 9.86 % and RSDs of the analysis were lower than 2,46% demonstrating the development of a precise analytical methodology.