A Rapid-Chemometrics Assisted RP-HPLC Method with PDA Detection for the Simultaneous Estimation of Ofloxacin and Nimorazole in Pharmaceutical Formulation

Abstract

A simple, rapid, sensitive, cost effective, and reproducible chemometrics assisted RP-HPLC method for the simultaneous estimation of the Ofloxacin and Nimorazole in pharmaceutical formulation was developed, optimized, and validated. A chemometrics assisted RP-HPLC method was developed. A developed method was optimized by using central composite design (CCD) in response surface methodology (RSM). Based on the trial and error, percentage of tetrahydrofuran in the mobile phase, flow rate, and buffer molarity were selected as factors. Resolution (Rs₂) and retention time (tR₂) were used for the estimation of system response during the optimization procedure. Derringer’s desirability function was used to concurrently optimize the selected two responses. Separation was achieved on a Phenomenex C₁₈ column (150 × 4.6 mm i.d, 5µ particle size) with a mobile phase consisting of 25% of Tetrahydrofuran and 75% of Phosphate buffer (25 mM), delivered at a flow rate of 1.2 mL/min with photodiode array detection at 294 nm. The developed and optimized method was fully validated for linearity accuracy, precision, robustness, and recovery. This validated method can be used for routine quality control analysis of ofloxacin and nimorazole in pharmaceutical dosage form.

Keywords:

• central composite design
• nimorazole
• oflaxacin
• response surface methodology
• RP-HPLC
• simultaneous estimation