Open AccessA Validated RP-HPLC Method for Estimation of Related Compounds in Hydroxy Naproxen
Author(s) -
L. Vaikunta Rao,
K. T. Venkateswara Rao,
V. V. Krishna Mohan Kandepi
Publication year - 2020
Publication title -
asian journal of chemistry/asian journal of chemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.145
H-Index - 34
eISSN - 0975-427X
pISSN - 0970-7077
DOI - 10.14233/ajchem.2020.22587
Subject(s) - chemistry , chromatography , naproxen , trifluoroacetic acid , detection limit , elution , high performance liquid chromatography , resolution (logic) , linearity , acetonitrile , correlation coefficient , analytical chemistry (journal) , medicine , physics , alternative medicine , statistics , mathematics , pathology , quantum mechanics , artificial intelligence , computer science
A simple, linear gradient liquid chromatographic method (RP-HPLC) is proposed for the simultaneousestimation of related compounds in hydroxy naproxen samples. Chromatographic separation wasachieved on Zorbax SB C8 (150 × 4.6) mm, 3.5 μm particle size RRLC short column and eluent Aused 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 weremonitored at 235 nm for related substance method and assay method. The excellent resolution wasobtained 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 ofdetection, limit of quantification, linearity, accuracy, precision and robustness. The correlationcoefficient(r) was > 0.995 for both the methods from linearity data and percentage of recovery is 98.0to 102.0 for assay method and 80.0 to 120.0% for related substance method. Sensitivity of the methodwas found be less than 0.5 μg/mL. Peak homogeneity data for naproxen in the chromatograms fromthe selectivity solution obtained by use of the photodiode array detector demonstrated the specificityof the method for analysis of hydroxy naproxen in presence of the related compounds