Development and validation of analytical methods for simultaneous estimation of propofol and lignocaine in bulk and parenteral formulation.

Abstract

A First order Derivative method and RP-HPLC method were developed and validated for simultaneous estimation of Propofol and Lignocaine in pharmaceutical dosage form. Accurate and precise UV spectrophotometric method with good sensitivity has been developed for simultaneous estimation of Propofol and Lignocaine. The method employed 1st order derivative method based on the measurement of absorbance of Propofol at ZCP 261.6 nm and Lignocaine at ZCP 270.8 nm. The calibration curve was linear in a concentration range of 40-240 μg/ml for Propofol and 10-60 μg/ml for Lignocaine. The RP-HPLC method has shown adequate separation of Propofol and Lignocaine in pharmaceutical dosage form. The separation was achieved on a Enable C18 (250 mm - 4.6 mm, 5 μm particle size) with an isocratic system of Methanol:Water in the ratio of 90:10 v/v. The mobile phase at a flow rate of 1.4 ml/min, Injection volume 20μl and wavelength of detection used was 267 nm. The retention time for Lignocaine and Propofol was obtained as 3.06 min and 3.57 min respectively. The linearity of the proposed method was investigated in the range of 100-600 μg/ml and 25-150 μg/ml for Propofol and Lignocaine respectively. The developed method was validated as per ICH guideline, for its accuracy, precision, robustness and the results were found to be satisfactory, thus the method is specific, rapid and simple with good sensitivity for estimation of Propofol and Lignocaine In Marketed dosage Form.