Table of Contents
Chromatography Research International
Volume 2016, Article ID 4909547, 5 pages
http://dx.doi.org/10.1155/2016/4909547
Research Article

Development and Validation of New RP-HPLC Method for Simultaneous Determination of Methyl and Propyl Parabens with Levetiracetam in Pure Form and Pharmaceutical Formulation

1Faculty of Pharmacy, Department of Pharmaceutical Chemistry, King Abdulaziz University, Jeddah 21589, Saudi Arabia
2Faculty of Pharmacy, Department of Analytical Chemistry, Zagazig University, Zagazig 44159, Egypt
3Quality Control Department, Egyptian International Pharmaceutical Industry Co., Tenth of Ramadan 44629, Egypt

Received 10 April 2016; Revised 23 June 2016; Accepted 26 June 2016

Academic Editor: Joselito P. Quirino

Copyright © 2016 Soad S. Abd El-Hay and Mostafa S. Mohram. 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.

Abstract

A simple and robust high-performance liquid chromatography (HPLC) method is described for the assay for levetiracetam (LTC), methyl paraben (MHB), and propyl paraben (PHB) either in their pure form or in commercial Levepsy® syrup. The method is selective and stability indicating and all chromatographic conditions were studied to obtain adequate separation of LTC, MHB, and PHB from their degradation products and from excipients. The HPLC separation was carried out on a RP C18 Hypersil BDS analytical column (150 mm × 4.6 mm ID) using gradient elution system. The mobile phase flow rate was 1.5 mLmin−1 and the column temperature was kept at 40°C. Complete separation of the studied components was obtained within a cycle time of 8 min. LTC, MHB, and PHB were eluted at 1.56, 5.86, and 7.85 min, respectively. Detection was carried out at 240 nm using a dual wavelength detector. The method has been validated for linearity, accuracy, precision, specificity, limit of detection, limit of quantitation, robustness, and ruggedness. The proposed method was successfully applied for the determination of LTC in the presence of parabens in Levepsy syrup.