Chemometric assisted UV spectrophotometric and RP-HPLC methods for simultaneous determination of paracetamol, diphenhydramine, caffeine and phenylephrine in tablet dosage form.

Abstract

In this paper, Chemometric assisted UV spectrophotometric and RP-HPLC methods were developed and compared for simultaneous determination of Paracetamol, Diphenhydramine Hydrochloride, Caffeine and Phenylephrine Hydrochloride in tablet dosage form. UV-Spectrophotometric analysis was carried out by applying two chemometric models namely, Principal Component Regression method (PCR) and Partial Least Squares Regression method (PLSR). Chromatographic method was developed and optimized by applying Response surface methodology -Central Composite Design (CCD). These methods were considered first for the quantification of the drugs present in the selected formulation. PCR and PLSR models were successfully validated and applied for resolving the complex UV-spectra in the wavelength range of 240-320nm with a data interval of 1nm. In RP-HPLC method, the identified critical factors were methanol content (45-55% v/v) and flow rate (0.75-0.85mL/min) and the selected responses were retention time (Rt4) of fourth eluted component and resolution (RS1,2) between first and second eluted components. Derringer's desirability function was used for the optimization of the chromatographic method conditions which comprised of mobile phase consisting of methanol‑potassium dihydrogen orthophosphate buffer (pH3; 10mM) (50: 50, v/v) and at a flow rate of 0.81mL/min with a detection wavelength of 220nm. One-way ANOVA in 95% confidence interval revealed that there were no significant differences among the developed methods.