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A Novel Ion-pair RP-HPLC Method For Simultaneous Quantification Of Naproxen And Esomeprazole In Pharmaceutical Formulations | 34639
ISSN: 2155-9872
Journal of Analytical & Bioanalytical Techniques
Open Access
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A rapid, sensitive and stability indicating ion-pair reversed-phase high-performance liquid chromatographic method was developed
for simultaneous estimation of naproxen (NPX) and esomeprazole (ESP) in pharmaceutical preparations. In our study, this
new method was used to overcome the instability problem of ESP during high performance liquid chromatographic analysis in the
presence of acidic drugs such as NPX. The method was validated according to ICH, FDA and USP guidelines with respect to accuracy,
precision, specificity, linearity, solution stability, robustness, sensitivity and system suitability. The method was developed by using an
isocratic condition of mobile phase comprising buffer [tetrabutylammonium hydroxide (0.0077 M) and n-heptane sulfonic acid–Na
salt (0.002 M), pH 7.6], acetonitrile and methanol in a 60:20: 20 v/v/v ratio at a flow rate of 1.5 mL/min over a C-18 (Octadecyl-silica,
5 mm, 250 3 4.6 mm) column at ambient temperature. The recovery for both drugs was found to be > 99% which demonstrated the
accuracy of this method. Intra- and inter-day precision studies of the new method were less than the maximum allowable limit [%
relative standard deviation (RSD) ≤ 2.0 according to FDA]. The method showed linear response with a correlation coefficient (r2)
value of 0.999 for both drugs. More importantly, ESP was quite stable in diluting solvent and mobile phase in the presence of NPX
for >3 days. Therefore, it was found to be an accurate, reproducible, sensitive and highly stability-indicating method and can be
successfully applied for routine analysis of simultaneous assay of NPX and ESP in pharmaceutical dosage forms.