HPLC method development and validation for rapid estimation of Etodolac related impurity-H in pharmaceutical dosage form
Objective: The objective of the study was to develop simple, rapid RP-HPLC method for the estimation of Etodolac related impurity-H pharmaceutical dosage form. Method: The chromatographic separation of Etodolac and its Impurity-H were done with a Kromasil C18, 150 4.6 mm, 5m particle size analytical column using the mobile phase acetate buffer and acetonitrile taken in 55:45% v/v and the response was detected at 221 nm by using PDA detector. Flow rate was maintained at 1 ml/min and temperature was set at 30 C. Results: Retention time of Etodolac was 3.1 min and Impurity-H was 8.3 min. The tailing factor and plate count of Impurity-H were 1.06 and 8913 respectively. The developed method was validated as per ICH guidelines. Mean percentage recovery obtained was 108.9%. Beer’s range was 2e12 mg/ml with correlation coefficient 0.999. The results of precision, LOD, LOQ, specificity and robustness were found within the limits. Conclusion: The proposed method was found to be simple, precise, accurate and rapid for quantitative determination of Etodolac related impurity-H in Etodolac pure drug and pharmaceutical dosage form. Key words: Etodolac, Impurity-H RP-HPLC.