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Article

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.
Sci. Pharm. 2014, 82(2), 341-356; https://doi.org/10.3797/scipharm.1401-11
Submission received: 14 January 2014 / Accepted: 27 February 2014 / Published: 27 February 2014

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

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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. https://doi.org/10.3797/scipharm.1401-11

AMA Style

AL AZZAM KM, YIT LK, 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. Scientia Pharmaceutica. 2014; 82(2):341-356. https://doi.org/10.3797/scipharm.1401-11

Chicago/Turabian Style

AL AZZAM, Khaldun M., Lee Kam YIT, Bahruddin SAAD, and Hassan SHAIBAH. 2014. "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" Scientia Pharmaceutica 82, no. 2: 341-356. https://doi.org/10.3797/scipharm.1401-11

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