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.
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