LC determination of lercanidipine and its impurities using DryLab software and experimental design procedures

Abstract

The main objective in all optimization procedures is to define the most appropriate conditions for rapid, sensitive, precise, and reproducible analysis, as economically as possible. Experimental design and DryLab optimization software have been used to optimize a liquid chromatographic method for separation of lercanidipine and its three impurities. In both methods of optimization the acetonitrile content and pH of the mobile phase were factors extracted for analysis; resolution of a critical pair was output in both cases. Data obtained from both optimization methods were compared and appropriate conclusions were extracted with the objective of gaining a complete view of chromatographic behavior. Detailed description was obtained by use of a three-dimensional graph and DryLab maps. Both methods of optimization reported the most appropriate mobile phase to be a 35:65 mixture of acetonitrile and an aqueous solution of 1.5% TEA, pH adjusted to 3.0 by addition of orthophosphoric acid, at a flow rate 1.0 mL min(-1). Separations were performed on a 20 x 4.6 mm, 3.5-mu m particle size, C-18 column, at 20 degrees C, with UV detection at 240 nm. The method was validated. All the results proved the reliability of the method, so it can be used for separation, identification, and simultaneous determination of these substances in the drug and in pharmaceutical dosage forms.