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Vol. 32 No. 5 (2020): Vol 32 Issue 5

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A Validated RP-HPLC Method for Estimation of Related Compounds in Hydroxy Naproxen

L. Vaikunta Rao
Department of Chemistry, GITAM Institute of Science, GITAM (Deemed to be University), Visakhapatnam-530045, India
K. Tirumala Rao
Analytical Research, Product and Technology Development, ecoLogic Technologies Limited, Hyderabad-500072, India
V.V. Krishna Mohan Kandepi
Process Research, Product and Technology Development, ecoLogic Technologies Limited, Hyderabad-500072, India

Corresponding Author(s) : L. Vaikunta Rao

lakinani.gitam@gmail.com

Asian Journal of Chemistry, Vol. 32 No. 5 (2020): Vol 32 Issue 5

Abstract

A simple, linear gradient liquid chromatographic method (RP-HPLC) is proposed for the simultaneous estimation of related compounds in hydroxy naproxen samples. Chromatographic separation was achieved on Zorbax SB C8 (150 × 4.6) mm, 3.5 μm particle size RRLC short column and eluent A used as 0.1% v/v trifluoroacetic acid in water and eluent B used as acetonitrile using Agilent RRLC (UHPLC) system. The mobile phase flow rate was 1.0 mL/min and the eluted compounds were monitored at 235 nm for related substance method and assay method. The excellent resolution was obtained between hydroxy naproxen and its related compounds, which were eluted within 25 min. The performance of the method was validated with respect to ICH guidelines for specificity, limit of detection, limit of quantification, linearity, accuracy, precision and robustness. The correlation coefficient(r) was > 0.995 for both the methods from linearity data and percentage of recovery is 98.0 to 102.0 for assay method and 80.0 to 120.0% for related substance method. Sensitivity of the method was found be less than 0.5 μg/mL. Peak homogeneity data for naproxen in the chromatograms from the selectivity solution obtained by use of the photodiode array detector demonstrated the specificity of the method for analysis of hydroxy naproxen in presence of the related compounds.

Keywords

Hydroxy naproxen Ultra-high performance liquid chromatography Rapid resolution liquid chromatography
Rao, L. V., Rao, K. T., & Mohan Kandepi, V. K. (2020). A Validated RP-HPLC Method for Estimation of Related Compounds in Hydroxy Naproxen. Asian Journal of Chemistry, 32(5), 1158–1164. Retrieved from https://asianpubs.org/index.php/ajchem/article/view/2497
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