LC–UV Method with Pre-Column Derivatization for the Determination of Ciclopirox Olamine in Raw Material and Topical Solution

摘要

A rapid, simple and sensitive liquid chromatographic method has been developed to assay ciclopirox olamine in raw material and topical solution. The analysis used a reversed-phase C₁₈ end-capped column, with UV detection at 305 nm and pre-column derivatization with dimethyl sulphate. A linear response (r 2 > 0.999) was observed in the range of 0.4–200 μg mL−1. The method showed good recoveries for the raw material and topical solution and the relative standard deviation intra and inter-day were ≤2.00%. Validation parameters such as specificity and robustness were also determined. The proposed method provided an accurate and precise analysis of ciclopirox olamine in raw material and topical solution.