Document Type : Original Article
Authors
1
University Institute of Pharmaceutical Sciences & Research, Baba Farid University of Health Sciences, Faridkot, India
2
Department of Microbiology, Viral Research Diagnostics Laboratory (VRDL), Guru Gobind Singh Medical College and Hospital, Baba Farid University of Health Sciences, Faridkot, India
3
Department of Pharmaceutical Chemistry, University Institute of Pharmaceutical Sciences and Research, Baba Farid University of Health Sciences, Faridkot
4
Dr. B C Roy College of PHARMACY and AHS, Durgapur-713206, West Bengal
5
Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala, India
6
UIPS, Panjab University, Chandigarh
Abstract
The aim of the investigation was to develop and validate a reversed-phase high-pressure liquid chromatography (RP-HPLC) method for the simultaneous estimation of etodolac and 5-FU in bulk and coated tablet dosage form. The method was validated in terms of linearity, precision, accuracy, and specificity, LOD, and LOQ according to ICH guidelines. The standard instrument parameters were optimized using C18 reverse phase Inertsil® ODS (250 × 4.6 mm, 5µ particle size) column with system equipped with photodiode array (PDA) detector. An optimized ratio of mobile phase in RP-HPLC under low pressure gradient mode comprising of 60:40 % v/v of acetonitrile and di-potassium hydrogen phosphate buffer (pH 6.4; 25 mM), provided sharp peaks (having adequate molar absorptivity at λmax of 280 nm) with short retention time of 4.3+/-0.2 and 11.5+/-0.3 min for 5-FU and etodolac, respectively. Results indicated the method was linear, precise, accurate, rugged and robust with RSD values <2%. The percentage recoveries of both the drugs were within the limits of 90-110% at various spiked concentrations. The proposed method was found to be highly effective and could be successfully employed for the quantification of 5-FU and ETD in bulk drug and tablet formulations for routine analysis.
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