Application of an Eco-friendly, Cost-effective Hydrotropic solution as mobile phase for the estimation and validation of Ornidazole in bulk and Pharmaceutical Formulation by RP-HPLC Remi L. S.1,*, Assistant Professor, Varkey Joyamma2, Nair A. Jayakumaran3, Sanjeev Vishnu. S.3 1PIPMS, Govt Medical College, Thiruvananthapuram, Kerala, India. 2T D Government Medical College, Alappuzha, Kerala. 3IUCGGT, University of Kerala, Karyavattom, Thiruvananthapuram. *Corresponding Author E-mail: remisanthosh@yahoo.com
Abstract A novel eco-friendly, safe and cost-effective RP-HPLC method was developed for the estimation of poorly water-soluble drug Ornidazole. In most of the RP-HPLC analysis toxic, volatile and expensive organic solvents are used as mobile phase. In the present study, an eco-friendly cost -effective hydrotropic solution (5%Urea in HPLC grade water) was employed as solubilizing agent and mobile phase for the estimation of poorly aqueous soluble drug Ornidazole by RP-HPLC. The analysis was carried out on Shimadzu LC6AD dual pump with PDA Detector SPD-M20A, and Rheodyne injector (20μl loop). The analytical column used was Shimadzu shim pack C is column with 5μm particle size and dimension of 4.6×250mm. Urea solution (5%) at a flow rate of l.0 ml/minute was employed as mobile phase and the drug was detected at 320 nm at ambient temperature. Novel eco-friendly mobile phase, comprising of 5% Urea solution was found to be satisfactory and give sharp peak for Ornidazole with retention time 3.996min. The method was validated as per ICH guidelines. Linearity was observed over the concentration range 10- 50μg/ml (R2=0.9990) with regression equation y=49321×+33223. Percentage recovery for Ornidazole was 99.36, indicates accuracy of the proposed method. The %RSD for both tablet analysis and recovery studies were less than 2% indicates high degree of precision. The LOD and LOQ values are 0.015771μg/ml and 0.047793μg/ml respectively, showed that the proposed method is sensitive. The developed method employing hydrotropic solution as mobile phase was novel, simple, precise, cost-effective, eco-friendly, safe and can be successfully applied for the routine analysis of Ornidazole in bulk and pharmaceutical dosage forms. Top Keywords Ornidazole, RP-HPLC, Hydrotropy, Hydrotropic mobile phase, Urea, Method validation. Top |