Abstract

Reverse phase HPLC method for the simultaneous estimation of lidocaine HCl, Prednisolone acetate and Dimethylsulfoxide in a pharmaceutical gel formulation

Author(s): Safeena Sheikh, Suhail Asghar, Showkat Ahmad, Anwar Daud

A simple, fast and reliable reverse-phase high-performance liquid chromatographic (HPLC) method was developed for the assay of Lidocaine HCl, Prednisolone acetate and Dimethylsulfoxide in a pharmaceutical gel formulation. Separation was achieved in a PrincetoneSPHRE 100 C18 column (250mm X 4.6mm, 5µ), using a mobile phase consisting of Acetonitrile: Potassium dihydrogen phosphate (0.01M) adjusted to pH 7.0 with triethylamine, in the ratio 54:46 (v/v) and a flow rate of 1.0mL/min. The detection was made with a UV detector measuring at the maximum for the compound. The validation study demonstrated that the method was precise, accurate and linear over the concentration range of analysis with a limit of detection for Dimethylsulfoxide, Prednisolone acetate and Lidocaine HCl was 5.0µg/ml, 10.5µg/ml and 50.0µg/ml respectively. The limit of quantification for Dimethylsulfoxide, Prednisolone acetate and Lidocaine HCl was found to be 20.0µg/ml, 35.0µg/ml and 180.00µg/ml respectively. Linear regression analysis for Dimethylsulfoxide, Prednisolone acetate and Lidocaine HCl was found in the range of 25-200µg/ml, 30-230µg/ml and 100-1000µg/ml gave correlation coefficients higher than 0.995 for all the three analytes. The method developed was applied to the analysis of Lidocaine HCl, Prednisolone acetate and Dimethylsulfoxide in a pharmaceutical gel formulation.