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8309222 
Journal Article 
Separation and determination of the R-isomer of etodolac in a bulk drug substance by normal-phase liquid chromatography 
Lawande, AB 
2016 
Innovare Academics Sciences Pvt. Ltd 
9 
6 
327-330 
English 
Objective: The objective of this work was to develop and validate a novel, simple, rapid, and reliable analytical method for separation and determination of R-isomer impurity in Etodolac bulk drug material by normal-phase high-performance liquid chromatography (HPLC) as per International Conference on Harmonization (ICH) guidelines. Methods: The etodolac R-isomer and S-isomer were separated on a Chiralcel OD-H (150 × 4.0 mm, 5 µm) column using ethanol: n-hexane: Trifluoroacetic acid (50:50:0.1 v/v.) mobile phase with equipped detector at wavelength 225 nm and 25°C column oven temperature. The resolution between R-isomer and S-isomer was more than two recorded on the chromatogram. The specified method was developed and validated for various parameters such as reproducibility, limit of detection (LOD), limit of quantification, linearity and range, robustness, solution stability and mobile phase stability according to the ICH guidelines. Results: Linearity was found for etodolac R-isomer over the concentration range of 600-6000 ng/ml, with the linear regression (correlation coefficient R = 0.998) and proved to be robust. LOD and limit of quantification of etodolac R-isomer were found to be 200 and 600 ng/ml. The retention time of R-isomer was considered to be 2.8 minutes. The percentage recovery of etodolac R-isomer has been ranged from 97.0 to 102.0 in bulk drug material sample. The proposed analytical method has been found to be suitable, precise, reliable and accurate for the separation and quantitative determination of etodolac R-isomer in bulk drug sample. Conclusion: A novel, speedy, accurate, precise, reliable and rugged analytical method have been developed and validated for normal phase HPLC to determine R-isomer impurity in etodolac bulk drugs material as per ICH guideline. © 2016 The Authors. Published by Innovare Academic Sciences Pvt Ltd. 
Etodolac; High performance liquid chromatography; Known impurity; Normal phase; Validation