Research Article | Volume: 6, Issue: 11, November, 2016

A Simple RP-HPLC Method Development and Validation for the Simultaneous Estimation of Naproxen and Rabeprazole

Mohammad Firoz KhanShaila Sharmin ZuthiMd. Shahidulla KayserMd. Shariful IslamSharmeen AsadMohammad A. Rashid   

Open Access   

Published:  Nov 29, 2016

DOI: 10.7324/JAPS.2016.601123
Abstract

A simple, economic, selective, accurate, precise reverse phase high performance liquid chromatographic method for the simultaneous estimation of naproxen and rabeprazole sodium in pure and pharmaceutical dosage forms was developed and validated. Naproxen and rabeprazole sodium were well separated using a phenomenex ODS C18 column of dimension 4.6 mm × 250 mm, 10 µm and mobile phase comprised of sodium dihydrogen phosphate buffer (pH 7.5±0.1) and acetonitrile in the ratio of 70:30 (v/v) at the flow rate 1 mL/min and the detection was performed at 275nm. The retention time for naproxen and rabeprazole sodium were found to be 3.33 ± 0.027 and 7.61 ± 0.043 min, respectively. The developed method was validated for specificity, linearity, precision and accuracy according to ICH guidelines. The proposed method is highly specific and linear over the concentration range of 2.0-60.0 µg/mL and 1.0-30.2 µg/mL for naproxen and rabeprazole sodium, respectively. The intraday precision (% RSD) of naproxen and rabeprazole sodium was in the range of 0.39 - 1.88% and 0.20 -1.51% while the interday precision ranged from 0.08 - 1.34% and 0.73 -0.87%, respectively. The accuracy (in terms of recover) of the method varied from 99.4-104.2% and 98.1-100.6% for naproxen and rabeprazole sodium, respectively. The LOD and LOQ of naproxen and rabeprazole sodium were found to be 0.6 and 0.1 µg/mL and 1.7 and 0.4 µg/mL, respectively. The sample solutions were stable for at least three hours. However, the developed method was successfully applied to assay naproxen and rabeprazole sodium brands available in Bangladesh.


Keyword:     NaproxenRabeprazole sodiumRetention timeSample stability.


Citation:

Khan MF, Zuthi SS, Kayser MS, Islam MS, Asad S, Rashid MA. A Simple RP-HPLC Method Development and Validation for the Simultaneous Estimation of Naproxen and Rabeprazole. J App Pharm Sci, 2016; 6 (11): 147-152.

Copyright:The Author(s). This is an open access article distributed under the Creative Commons Attribution Non-Commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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