RP-HPLC Method Development and Validation for the Simultaneous Estimation of Etodolac and Paracetamol in Tablet Dosage Form

Abstract

A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and
validated for simultaneous determination of Etodolac and Paracetamol in pharmaceutical tablet dosage form.
Chromatographic analysis was performed on a Symmetry X-terra C8 (4.6mm x 150mm,5m) column at
ambient temperature with a mixture of mixed ortho phosphoric acid buffer and Acetonitrile in the ratio 50:50
v/v OPA buffer ; as mobile phase, at a flow rate of 0.9 mL min-1
. UV detection was performed at 260 nm. The
method was validated for accuracy, precision, linearity and sensitivity. The retention times of Etodolac and
Paracetamol were 2.190 and 3.373 min, respectively. Calibration plots were linear over the concentration ranges
4–20 μg mL-1
and 5-25μg mL-1
for Etodolac and Paracetamol, respectively. The Limit of detection was 0.361
and 0.559µg mL-1
and the quantification limit were 1.203 µg mL-1
and 1.864µg mL-1 for Etodolac and
Paracetamol, respectively. The accuracy of the proposed method was determined by recovery studies and found
to be 99.23% to 99.93%. Commercial tablet formulation was successfully analyzed using the developed method
and the proposed method is applicable to routine analysis of determination of Etodolac and Paracetamol in
pharmaceutical tablet dosage form.