3PC-011 Hplc method development and validation to determinate resorcinol for quality control in pharmaceutical formulations

BackgroundThe hidradenitis suppurativa (HS) is an inflammatory skin disease. Resorcinol is a phenol derivate, and in topical self-treatment decreases the size and pain of HS lesions. Topical 15% resorcinol is prepared as a pharmaceutical compound. In current literature, high performance liquid chromatography (HPLC) methods have been reported for determination of resorcinol, using different gradients of mobile phase mainly.PurposeTo assess the correct formulation, our objective is to develop an isocratic HPLC method for quality control.Material and methodsTo develop and validate the method, an Agilent 1260 HPLC system was used. Performed at 25°C, the separation was carried out in reverse phase column (Agilent Zorbax Eclipse XDB-C18 4.6 mm x 250 mm, 5 µm i. d.) (USA) with an isocratic mode. The mobile phase was methanol:water 40%:60%, the flow rate was 1 mL/minute and the injection volume was 10 mcL. A diode array detector was used (=280 nm). All reagents were analytical grade and bought from Sigma-Aldrich (USA). The calibration line was generated by least squares linear regression. The method accuracy (acceptance criterion of 99%–101%) and precision performed in a within-day and between-day anaylisis (five consecutive days) was assessed by five replicates run (low-, medium- and high-level concentration) and