A RAPID - CHEMO METRICS ASSISTED RP-HPLC METHOD WITH PDA DETECTION FOR THE SIMULTANEOUS ESTIMATION OF OFLOXACIN AND NIMORAZOLE IN PURE AND PHARMACEUTICAL FORMULATION

P. Giriraj, T. Sivakkumar*

ABSTRACT

A simple, rapid, sensitive, cost effective and reproducible chemo metrics assisted RP-HPLC method was developed, optimized and validated for the simultaneous estimation of the Ofloxacin and Nimorazole in pure and pharmaceutical formulation. The developed method was optimized by using Central composite design (CCD) in resoponse surface methodology (RSM). Based on the trial and error, percentage of tetrahydrofuran in 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 of ofloxacin and nimorazole was achieved on phenomenex C18 column (150 X 4.6 mm i.d, 5μ particle size) with a mobile phase consisting of 25% of tetrahydrofuran and 75% of Phosphate buffer (25mM) was delivered at a flow rate of 1.2mL/min and photodiode array detection at 235nm. The method was found to be linear over the concentration range of 20 – 60μg/mL for ofloxacin and 50 – 150μg/mL for nimorazole with their correlation coefficient values of 0.9995 and 0.9997 respectively. LOD and LOQ were found to be 20.62ng/mL and 62.49ng/mL for ofloxacin, 188.65ng/mL and 571.68ng/mL for nimorazole. The % RSD value of accuracy and precision study was found to be less than 2%. The proposed method is simple, rapid, sensitive, cost effective and reproducible. Hence

Keywords: this method can be used for routine quality control analysis of ofloxacin and nimorazole in pure and pharmaceutical dosage form