Abstract
A simple, accurate, sensitive and reproducible reverse phase high performance liquid chromatographic method has been developed for the quantitative determination of Etoricoxib in pharmaceutical dosage forms. The assay was performed on Hypersil ODS C-18 (250 x 4.6 mm., 5µm particle size) column using acetonitrile and potassium dihydrogen phosphate buffer (pH 4.2) (46:54 % v/v) as mobile phase with UV detection at 280 nm (flow rate 1.2 ml/min). Bromhexine was used as an internal standard. Quantization was achieved by measurement of the peak area ratio of the drug to the internal standard. The limit of detection (LOD) and the limit of quantification (LOQ) were 0.0704 µg ml-1and 0.2134 µg ml-1respectively. Each analysis required no longer than 10 minutes. The calibration curve was linear over the concentration range from 0.5-85.0 µg ml-1. The retention times of Etoricoxib and Bromhexine were found to be 3.083 and 7.631 minutes respectively. The proposed method was validated according to the ICH guidelines and can be used successfully to analyse marketed formulations.
Highlights
Etoricoxib[1] (ETC) (Figure 1) is a new non-steroidal anti-inflammatory drug (NSAID) which is chemically 5-chloro-6 -methyl-3-[4-(methylsulphonyl) phenyl]-2,3 -bipyridine
A simple, accurate, sensitive and reproducible reverse phase high performance liquid chromatographic method has been developed for the quantitative determination of Etoricoxib in pharmaceutical dosage forms
Etoricoxib is preferred over conventional NSAIDs as they may lead to serious gastrointestinal complications such as ulcer, severe bleeding and perforation resulting in hospitalization and even death[5]
Summary
Etoricoxib[1] (ETC) (Figure 1) is a new non-steroidal anti-inflammatory drug (NSAID) which is chemically 5-chloro-6 -methyl-3-[4-(methylsulphonyl) phenyl]-2,3 -bipyridine It inhibits the synthesis of prostaglandins by inhibiting the activity[2,3] of the enzyme, cyclooxygenase-2. Stock solution of internal standard was prepared by dissolving 25 mg of Bromohexine in 25 ml of volumetric flask containing 10 ml of mobile phase, sonicated for 20 min. Linearity A series of standard solutions of Etoricoxib were prepared by taking suitable aliquots of drug solution (0.5-85 μg mL-1) from the stock solution and spiked with internal standard solution (Bromohexine, IS) (10 μg mL-1) and the volume was made up to 10 ml with mobile phase in a 10 ml volumetric flask. A calibration curve was constructed by taking concentration of ETC on x-axis and the corresponding peak area ratios on y-axis (Figure 3)
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