UV Spectrophotometric and Stability Indicating RP-HPLC Assay Methods for the Estimation of Etodolac in Bulk and Tablet Dosage Form

Abstract

Objectives: The present article involved the development of sensitive and validated reverse phase liquid chromatographic and UV-spectrophotometric method for the determination of etodolac in bulk and pharmaceutical dosage form. Methods: The presents UV method is based on measurement of absorption at maximum at 226 nm using methanol and water (70:30) as a solvent. The stock solution of etodolac was prepared and subsequent suitable dilution was prepared in distilled water to obtained standard curve. The standard solution of Etodolac shows absorption maxima at 226 nm. Results: The drug obeyed beer lambert’s law in the concentration range of 2-20 μg/ml with regression coefficient 0.9998 at 226 nm. The chromatographic method was optimised using Phenomenex Luna C18, 100A, 5mm, 250mm x 4.6mm i.d. column with UV detection at 226 nm and Acetonitrile: Methanol in 65:35 ratio at a flow rate of 1.0 ml/ min. The proposed method was successfully applied to the determination of Etodolac in bulk and pharmaceutical dosage form. The method was found linear over the range of 0 – 48 μg/ml. The recovery was observed in the range of 98% to 102% and limit of detection and limit of quantification were found to be 0.08 μg/ml and 0.26 μg/ml. Different analytical performance parameters such as precision, accuracy, limit of detection, limit of quantification and robustness were determined and found satisfactory according to International Conference on Harmonization (ICH) guidelines. Conclusion: The developed methods were found reliable, easy and validated for the estimation of etodolac in bulk and tablet dosage form.