Abstract

DEVELOPMENT AND VALIDATION OF REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS ESTIMATION OF PARACETAMOL AND PAMABROM IN COMBINED DOSAGE FORM

Hetal H. Patel*, Mr. Hemant Patel

ABSTRACT

A HPLC method has been described for simultaneous determination of Paracetamol and Pamabrom in formulation. This method is based on HPLC separation of the two drugs ODS HyperSil C-18 column [250mm, 4.6m, 5μm], with isocratic conditions and mobile phase containing Phosphate Buffer(pH 4.8):Acetonitrile(85:15) at a flow rate of 1 ml/min, using UV detection at 267 nm.This method has been applied to formulation without any interference of excipients of formulation. The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration range of 10-60 μg/ml for Paracetamol, 2-12μg/ml for Pamabrom respectively. The mean values of the correlation coefficient, slope and intercept were 0.9983, 123096 and 109892 for Paracetamol, 0.9996, 57564and 154136 for Pamabrom respectively. The method was validated as per the ICH guidelines. The limit of detection (LOD) and limit of quantitation (LOQ) was 0.17μg/ml and 0.19μg/ml for Paracetamol and0.52μg/ml and 0.59μg/ml for Pamabrom respectively. Statistical analysis showed that the method is repeatable and selective for the estimation of Paracetamol and Pamabrom.

Keywords: Paracetamol, Pamabrom, HPLC, Validation, simultaneous estimation.