Development and Validation of RP-HPLC Method for Estimation of Lidocaine in Various Pharmaceutical Dosage Forms

Abstract

Objective: To develop extraction procedures for extracting Lidocaine from various pharmaceutical dosage forms (ointment, gel, injection, aerosol, transdermal patch) and to analyze them by development of accurate, precise and robust reverse phase high performance liquid chromatography method.
Method: Chromatographic procedures were developed using Chromatopak, Peerless C18 column (Column dimensions: 250 mm x 4.6 mm, 5 μm) with mobile phase comprising of Dipotassium monohydrogen phosphate buffer (10Mm): ACN in ratio 20:80 at a flow rate of 1ml/min, with detection wavelength at 263nm. The retention time of Lidocaine was found to be at 5.43±0.03.
Results: The method was validated according to ICH guidelines (Q2) R1.Linearity of LID was found in concentration range of 20-100ug/ml with r2=0.999. Limit of Detection and Limit of Quantification were found to be 1.54ug/ml and 4.68ug/ml. %RSD values for intraday and interday precision were also found to be >2%. Accuracy studies were also in range between 95%-105%. The method proved to be robust when chromatographic parameters like Ph, mobile phase ratio, flow rate, wavelength were altered.
Conclusion: The % Assay values of marketed formulation were found to be within prescribed range. Thus this proposed RP-HPLC method can be used in routine quality control analysis of LID from its various pharmaceutical dosage forms.