ISSN : 0975-9492


Open Access

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Title : New Analytical Methods and Their Validation for the Estimation of Etodolac in Bulk and Marketed Formulations
Authors : Mona Bhalani, Dr. E.V.S. Subrahmanyam, Dr. A. R. Shabaraya
Keywords : etoodolac, p-dimethylaminocinnamaldehyde, ferric chloride hexahydrate, hydrogen peroxide.
Issue Date : February 2015
Abstract :
Etodolac is non-steroidal anti-inflammatory drug. It is used for the management of mild to moderate pain, fever and inflammation. Purpose: Analytical methods are required to characterize drug substances and drug products composition during all phases of pharmaceutical development. Development of methods to achieve the final goal of ensuring the quality of drug substances and drug products must be implemented. This determination requires highly sophisticated instruments and methods like HPLC, HPTLC and Spectrophotometer. Hence there was a need for the development of newer, simple, sensitive, rapid, accurate and reproducible analytical methods for the routine estimation of etodolac in bulk and pharmaceutical dosage form. Methods: Two simple, sensitive, specific and validated methods (method A and method B) have been developed for the quantitative estimation of etodolac in bulk and pharmaceutical dosage form. Method A is based on reaction of etodolac with p-dimethylaminocinnamaldehyde to produce orange colour chromogen which showed ?max at 526.8 nm. In method B, etodolac oxidizes in presence of ferric chloride and hydrogen peroxide which absorbs at ?max at 537.2 nm. Reults: The linearity was found in concentration range of 5-30g/ml and 2-12g/ml for method A and method B respectively. The correlation coefficient was found to be 0.9990 and 0.9966 for method A and method B respectively. The methods were validated as per ICH guidelines. The LOD and LOQ for estimation of etodolac were found as 0.0824, 0.0230 for method A and 0.2498, 0.0699 for method B respectively. Conclusions: Proposed methods were successfully applied for the quantitative estimation of etodolac in marketed formulations.
Page(s) : 414-416
ISSN : 0975-9492
Source : Vol. 6, No.2