Development and validation of RP-HPLC method for estimation of Tapentadol hydrochloride in bulk and tablet dosage forms

Objective

To develop a simple, novel, sensitive, precise and specific RP-HPLC method for the determination of Tapentadol hydrochloride in bulk and its tablet dosage forms.

Methods

The chromatographic separation was achieved on C18 Licrosphere column (150 mm × 4.6 mm inner diameter, 5 μm particle size) as a stationary phase using Methanol: 0.1 mM Dipotassium Phosphate buffer (pH 4, adjusted with ortho phosphoric acid) as mobile phase at detection wavelength 280 nm in isocratic mode at a flow rate of 1 ml/min.

Results

The calibration curve for Tapentadol hydrochloride was linear from 75 to 450 μg/ml. The correlation coefficient (r²) value was found to be 0.9994. Precision study showed % CV value less than 2% in all selected concentrations. The % recoveries of Tapentadol hydrochloride are in the range of 99.96–100.01%. The limit of detection and limit of quantification for Tapentadol hydrochloride were found to be 0.25 μg/ml and 0.75 μg/ml respectively.

Conclusion

The developed method has good sensitivity, reproducibility and specificity for the determination of Tapentadol hydrochloride in bulk and its tablet dosage forms. This method was simple, fast, accurate, and precise. Hence this method was validated and found to be suitable for determining the purity of Tapentadol hydrochloride in bulk drugs and pharmaceutical formulations. The proposed validated method was successfully used for the quantitative analysis of commercially available dosage form.