The aim of this study was to develop and verify a simple, rapid and sensitive high performance liquid chromatography method coupled with UV detector (HPLC-UV) method for the quantitative determination of etodolac in bulk and pharmaceutical dosage forms. Chromatographic separation was performed at ambient conditions on a reverse phase ACE C8 analytical column (250 mm x 4.6 mm ID, 5 umm) using the mobile phase containing acetonitrile-water (80:20, v/v) at a flow rate of 1.0 mL min-1. A wavelength of 272 nm was used for etodolok and paracetamol (IS). A retention time of 4.21 min and 2.02 min were obtained for etodolac and IS, respectively. The method showed linearity in the range of 0.08-10 µg mL-1 for etodolac (R = 0.9999). The linear regression equations obtained by least square regression method were the ratio of peak area of etodolac and IS =1.559 concentration (etodolac µg/mL) - 0.139. The intra-day and inter-day RE% and RSD% values of the method were =10.0% and =2.65%, respectively. Limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.04 and 0.06 µg mL-1 for etodolac, respectively. A new, simple and sensitive high performance liquid chromatography method was developed and validated for etodolac. The method can be applied for the quantification of etodolac without derivatization in bulk solutions and commercial formulations using the internal standard.
HPLC, etodolac, validation, formulation
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