Implementation of factorial design for optimization of forced degradation conditions and development of validated stability indicating RP-HPLC method for Lidocaine hydrochloride

摘要

A simple rapid stability-indicating RP-HPLC assay method was developed and validated for quantitative determination of lidocaine hydrochloride in bulk and ampoule dosage form. Lidocaine hydrochloride (drug and drug product) was subjected to acid and alkali hydrolysis, oxidation by hydrogen peroxide and photo-degradation. Experimental factorial design has been used during forced degradation to determine significant factors responsible for degradation and to optimize degradation conditions reaching maximum degradation. 23 Full factorial design has also been used to optimize chromatographic conditions. The chromatographic conditions obtained from factorial design involve the use of phosphate buffer (pH 6.0) and acetonitril (55:45, v/v) as mobile phase at a flow rate of 1.7 mL/min. Inertsil ODS-3(250 mm x 4.6 mm, 5μm) column was used as stationary phase and the detection was performed at 220 nm using PDA detector. The method was successfully applied to the determination of Lidocaine hydrochloride in ampoule dosage form, and the percent recovery +/- standard deviation (SD) was 98.95 ± 0.33. The method was validated as per ICH guidelines. The method was found to be simple and rapid with less trial and error experiments by making use of factorial design.