Abstract:
A RP-HPLC method was developed for simultaneous estimation of Paracetamol
and Tapentadol Hydrochloride in tablet Dosage form. The calibration curve was
linear in a concentration range of 32.5-97.25μg/ml for Paracetamol and 5-
15μg/ml for and Tapentadol Hydrochloride. The RP-HPLC method has shown
adequate separation of Paracetamol and Tapentadol Hydrochloride in Tablet
Dosage Form. The separation was achieved on a BDS C18 (250mm x 4.6mm i.d.,
5μm particle size) with an gradient system of Water: Methanol: Tri Ethyl Amine
(TEA) in the ratio of (60:40:0.1) v/v. The mobile phase at a flow rate of 1.0
ml/min, Injection volume 20μl and wavelength of detection used was 217nm. The
retention time for Paracetamol and Tapentadol Hydrochloride was obtained as
3.920±0.1min and 5.307±0.1min, respectively. The linearity of the proposed
method was investigated in the range of 32.5-97.5μl/ml and 5-15μl/ml for
Paracetamol and Tapentadol Hydrochloride, respectively. Correlation coefficient
was 0.998 and 0.997 for Paracetamol and Tapentadol Hydrochloride,
respectively. The developed method was validated as per ICH guideline, for its
accuracy, precision, LOD & LOQ and the Assay results were found to be
satisfactory, thus the method is specific, rapid and simple with good sensitivity
for estimation of Paracetamol and Tapentadol Hydrochloride. This analytical
method is also applicable in ordinary laboratories. It can also be adopted for
quality control tests for these drugs in tablet.