Development and validation of HPLC method for simultaneous determination of lidocaine and prilocaine in topical formulation

Abstract

Objective: A simple, specific, accurate, and precise method, namely, reverse phase high-performance liquid chromatography was to develop for simultaneous estimation of Lidocaine (LDC) and prilocaine (PLC) in a topical local anesthetic cream. Method: The mixture of PLC and LDC was separated on Hi Q Sil C18 HS column, (250 mm × 4.6 mm, 5 μm), column temperature ambient and flow rate 1.2 mL/minutes. The mobile phase was acetonitrile: 0.01 M diethylamine solution (pH adjusts to 6.8 with orthophosphoric acid) (60:40) with detection at 225 nm. Results: The retention time was found to be 6.075±0.12 minutes for PLC and 8.642±0.15 minutes for LDC, respectively. Linearity was observed in the concentration range of 1-6 μg/mL for both LDC and PLC, respectively. The method was validated according to International Conference on Harmonization guideline and values of linearity, precision, robustness, limit of detection, limit of quantitation, selectivity, and recovery were found to be in good accordance with the prescribed value. Conclusion: The proposed method can be useful in the quality control of LDC and PLC in their topical formulation.