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
| Autor: | Khaldun M. Al Azzam, Lee Kam Yit, Hassan Shaibah, Bahruddin Saad |
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| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
Chromatography
Tablet dosage form Capillary zone electrophoresis Zolpidem Tartrate Pharmaceutical Science Electrolyte Dosage form chemistry.chemical_compound Stability indicating Capillary electrophoresis chemistry Forced degradation Degradation (geology) Phosphoric acid Zolpidem tartrate Research Article |
| Zdroj: | Scientia Pharmaceutica Volume 82 Issue 2 Pages 341-356 |
| ISSN: | 2218-0532 0036-8709 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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