European Journal of Biomedical and Pharmaceutical Sciences

A RAPID - CHEMOMETRIC ASSISTED RP- HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF PARACETAMOL AND FLUPIRTINE MALEATE IN PHARMACEUTICALS

P. Giriraj, T. Sivakkumar*

ABSTRACT

Simple, fast, accurate and precise RP-HPLC-PDA method was developed and optimized with the assist of chemometric tool for the simultaneous estimation of paracetamol and flupiritine maleate in pharmaceutical dosage form. Optimization of the method was done by central composite design in response surface methodology. Percentage of organic phase (acetonitrile) in mobile phase, molarity of the buffer and flow rate were selected as factors. Retention time and resolution were chosen for the estimation of system responses during the optimization procedure. Based on the trail runs, the optimized condition generated by the software was used for the separation of Paracetamol and flupiritine maleate on phenomenex C18 Column (150 mm X 4.6 mm i.d., 5 μm). Chromatographic separation was achieved by using mobile phase consisting of acetonitrile and Phosphate buffer (45; 55), adjusted to pH 3.5, delivered at a flow rate of 1.2 mL/min and the detection was carried out at 245nm. Retention times were 1.182 min and 1.915 min for paracetamol and flupirtine maleate respectively. Developed method was fully validated as per ICH guidelines. Calibration curves of paracetamol and flupirtine maleate were found to be linear in the range of 32.5- 97.5 μg/mL and 10 - 30 μg/mL, respectively. Recoveries for the two compounds were close to 100 % at various levels. Hence the proposed method is found to be rapid, simple, accurate, precise and robust and is suitable for the routine quality control analysis.

Keywords: Central composite design, Derringer’s desirability function, Flupirtine maleate, Paracetamol, Response surface methodology, RP-HPLC.