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Sci. Pharm. 2014, 82(2), 341-356; doi:10.3797/scipharm.1401-11

Development and Validation of a Stability-Indicating Capillary Electrophoresis Method for the Determination of Zolpidem Tartrate in Tablet Dosage Form with Positive Confirmation using 2D- and 3D-DAD Fingerprints

1
Faculty of Pharmacy, Isra University, 11622 Amman, Jordan
2
Pharmacy Program, Batterjee Medical College for Science and Technology (BMC), 21442 Jeddah, Kingdom of Saudi Arabia
3
School of Chemical Sciences, Universiti Sains Malaysia, 11800 Penang, Malaysia
*
Authors to whom correspondence should be addressed.
Received: 14 January 2014 / Accepted: 27 February 2014 / Published: 27 February 2014
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Abstract

The aim of the current study was to develop a simple, precise, and accurate capillary zone electrophoresis method for the determination of zolpidem tartrate in tablet dosage form. Separation was conducted in normal polarity mode at 25°C, 22 kV, using hydrodynamic injection for 10 s. Separation was achieved using a background electrolyte of 20 mM disodium hydrogen phosphate adjusted with phosphoric acid (85%), pH at 5.50, and detection at 254 nm. Using the above optimized conditions, complete determination took place in less than 3 min using amiloride HCl as the internal standard. The method was linear over the range of 3–1000 μg mL−1 with a correlation coefficient of 0.9999. Forced degradation studies were conducted by introducing a sample of zolpidem tartrate standard and pharmaceutical sample solutions to different forced degradation conditions, being neutral (water), basic (0.1 M NaOH), acidic (0.1 M HCl), oxidative (10% H2O2), temperature (60°C in oven for 3 days), and photolytic (exposure to UV light at 254 nm for 2 h). Degradation products resulting from the stress studies did not interfere with the detection of zolpidem tartrate and the assay can be considered stability-indicating.
Keywords: Zolpidem tartrate; Capillary zone electrophoresis; Tablet dosage form; Stability indicating Zolpidem tartrate; Capillary zone electrophoresis; Tablet dosage form; Stability indicating
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. (CC BY 4.0).

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MDPI and ACS Style

AL AZZAM, K.M.; YIT, L.K.; SAAD, B.; SHAIBAH, H. Development and Validation of a Stability-Indicating Capillary Electrophoresis Method for the Determination of Zolpidem Tartrate in Tablet Dosage Form with Positive Confirmation using 2D- and 3D-DAD Fingerprints. Sci. Pharm. 2014, 82, 341-356.

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