Development and validation of stability indicating HPLC method for the estimation of etodolac in pharmaceutical dosage form
Nagaraju Pappula, D Mounika, V Mounika
A rapid, simple, precise, accurate, and isocratic high performance liquid chromatography (HPLC) method has been developed for routine quality control of etodolac in pharmaceutical formulations. Separation was carried out by C18 column. The mobile phase was a mixture of solvent A (80:20%v/v – buffer and acetonitrile) and solvent B (75:25%v/v acetonitrile and buffer) in gradient mode at a flow rate of 1 mLmin-1. The ultraviolet (UV) detection and column temperature were 227 nm and ambient in nature. The run time was 15 min under these chromatographic conditions. Excellent linear relationship between peak area and etodolac concentration in the range of 0.04-1 µg mL-1 has been observed (r2, 0.998). Developed method has been found to be sensitive, precise (the interday and intraday relative standard deviation (RSD) values for peak area was less than 0.4, accurate (recovery, 97.3-97.7%), specific and robust (% RSD were less than 1.00, for system suitability parameters). Proposed method has been successfully applied for quantification of etodolac in pharmaceutical formulations.
Nagaraju Pappula, D Mounika, V Mounika. Development and validation of stability indicating HPLC method for the estimation of etodolac in pharmaceutical dosage form. International Journal of Chemistry Studies, Volume 5, Issue 1, 2021, Pages 05-10