Box Behnken Design (BBD) Application for Optimization of Chromatographic Conditions in RP-UPLC Method Development for Simultaneous Determination of Paracetamol, Cetirizine and Phenylephrine in Api and Tablet Dosage Forms

Abstract

Introduction: An accurate, quick, and precise reversed phase UPLC technique has been created to determine the pure concentrations of phenylephrine(phy), cetirizine(ctz), and paracetamol(para) with a box behnken design (BBD) application. BBD was employed to optimize the chromatographic conditions for analytical methods.

Objectives: The purpose of this work is to create a stability-indicating reverse phase UPLC method and validate it according to ICH Q2(R1) guidelines. that will fill a research gap as it enhances the three parameters i.e. speed, resolution, and sensitivity.

Methods:  RP-UPLC method was carried out by pumping Mobile phase at a flow rate of 0.3 ml/min i.e. methanol and buffer in a ratio of 55:45 A. This approach employed  K₃PO₄  as a buffer. A constant 24°C temperature was maintained. 280 nm was the optimal wavelength for paracetamol, cetirizine, and phenylephrine.

Results: The retention durations for phenylephrine, cetirizine  and paracetamol were determined to be 1.895, 1.173, and 0.710 minutes, respectively. It was identified that the % RSD of the system precision for phenylephrine, cetirizine, and paracetamol was 0.4,0.3, 0.4 and method precision was identified to be 0.2, 0.4 and 1.1 respectively. The percentage recovery for paracetamol, cetirizine, and phenylephrine was found to be 100.40%, 99.73% and 100.12%, respectively. The regression equations for paracetamol, cetirizine, and phenylephrine yielded LOD and LOQ values of 1.26 µg/ml, 0.07 µg/ml, 0.02 µg/ml, 3.83 µg/ml, and 0.21 µg/ml, 0.05 µg/ml, respectively. The regression equations for cetirizine (y = 19458x + 602.07), phenylephrine (y = 19316x  + 797.53), and paracetamol (y = 18109x + 8212.5) were found.

Conclusions: A simple, Accurate, precise method was developed for the simultaneous estimation of the paracetamol, cetirizine and phenylephrine in solid dosage form. The %RSD of system precision for paracetamol, cetirizine and phenylephrine was found to be 0.4, 0.3, 0.4. R_t for these three drugs were determined to be 0.710, 1.173 and 1.895 min since retention times are shortened, the approach created was valued.