A novel ecofriendly, cost effective mobile phase for hplc- simultaneous estimation and validation of paracetamol and diclofenac sodium in bulk and pharmaceutical formulation by rp-hplc using hydrotropic solution as mobile phase
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High performance liquid chromatography of drugs is usually performed with the help of organic mobile phase like Methanol, Acetonitrile etc., which are toxic, volatile and expensive. In the present study, an Ecofriendly cost-effective hydrotropic solution (5% Urea in HPLC grade water) was employed as mobile phase for the estimation of poorly aqueous soluble drugs Paracetamol and Diclofenac sodium 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 C18 column with 5μm particle size and dimension of 4.6×250mm. Urea solution (5%) at a flow rate of 1.0mL/minute was employed as mobile phase and the drugs were detected at 268nm at ambient temperature. Novel ecofriendly mobile phase, comprising of 5% Urea solution was found to be satisfactory and give sharp peaks for Paracetamol and Diclofenac sodium with retention time 3.272 and 1.772 min respectively. The method was validated as per ICH guidelines. Linearity for detector response was observed in 100- 500μg/mL for Paracetamol and 10- 50μg/mL for Diclofenac sodium. Percentage recovery for Paracetamol and Diclofenac sodium were 99.97 and 99.79 respectively, 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 showed that the proposed method is sensitive. Therefore, the developed method employing hydrotropic solution as mobile phase was novel, simple, precise, cost effective, ecofriendly, safe and can be successfully applied for the routine analysis of Paracetamol and Diclofenac sodium in pharmaceutical dosage forms.
Paracetamol, Diclofenac sodium, RP-HPLC, Hydrotropic mobile phase, Urea, Method validation.