title: 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.
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.
authors: Faculty of Pharmacy, Isra University, 11622 Amman, Jordan. ; Pharmacy Program, Batterjee Medical College for Science and Technology (BMC), 21442 Jeddah, Kingdom of Saudi Arabia.
authors: Khaldun M
authors: KM
authors: Al Azzam
authors: School of Chemical Sciences, Universiti Sains Malaysia, 11800 Penang, Malaysia.
authors: Lee Kam
authors: LK
authors: Yit
authors: School of Chemical Sciences, Universiti Sains Malaysia, 11800 Penang, Malaysia.
authors: Bahruddin
authors: B
authors: Saad
authors: Pharmacy Program, Batterjee Medical College for Science and Technology (BMC), 21442 Jeddah, Kingdom of Saudi Arabia.
authors: Hassan
authors: H
authors: Shaibah
keywords: Capillary zone electrophoresis; Stability indicating; Tablet dosage form; Zolpidem tartrate