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E-Journal of Chemistry
Volume 9, Issue 1, Pages 35-42

RP-HPLC Method Development and Validation for the Determination and Stability Indicative Studies of Montelukast in Bulk and its Pharmaceutical Formulations

A. Patnaik,1 S. S. Panda,1 S. Sahoo,1 and V. J. Patro2

1Saraswati College of Pharmaceutical Sciences, Yethbarpally(v), Moinabad (M), R. R. Dist, Andhra Pradesh, India
2Roland Institute of Pharmaceutical Sciences, Khodasinghi, Berhampur, Ganjam, Orissa, India

Received 12 March 2011; Accepted 30 April 2011

Copyright © 2012 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


A simple, precise, accurate, economical and reproducible HPLC method for estimation of montelukast in tablet dosage form has been developed. Quantitative HPLC was performed with Shimadzu LC2010c HT with Winchrom Software with UV-Visible detector (SPD-IOA), PUMP (LC-IOAT) and (LC-IOATvp). Phenomenex C8, 5 μm, 25 cm × 4.6 mm i.d. column was used in the study. The mobile phase of ACN: Acetate buffer= 6.5:3.5 of pH 3 were used in this study. The conditions optimized were: flow rate (1 mL/minute), wavelength (222 nm) and run time was 20 min. Retention time was found to be 3.08 min. The linearity was found to be in the concentration range of 10-100 μg/mL. The developed method was evaluated in the assay of commercially available tablet moni containing 10 mg of montelukast. The amount of drug in tablet was found to be 10.34 mg/tab for the brand. Results of analysis were validated statistically and by recovery studies. The recovery studies 99.67% was indicative of the accuracy of proposed method. The precision was calculated as repeatability, inter and intraday variation (%RSD) for the drug. By using the method, stability of the drug has been studied.