Development and Validation of Rapid, Sensitive Rp-Uplc Method for Determination of Related Impurities in Dexrabeprazole Sodium
作者: Santosh T. KhadangaleVitthal. M. DhalapeRahul V. Pinjari
刊名: Oriental Journal of Chemistry, 2018, Vol.34 (5)
来源数据库: Material Science Research India
DOI: 10.13005/ojc/340526
关键词: Dexrabeprazole Sodium(DEX•Na)Lower Level Quantification and DetectionRapidRP-UPLCSensitiveStability Indicating
原始语种摘要: Dexrabeprazole sodium (DEX•Na) is an active pharmaceutical ingredient and used as proton pump inhibitor. A reverse phase (RP) ultra-performance liquid chromatographic (UPLC) method is developed for determination of related impurities in DEX•Na and this method is validated using ICH guideline. This method was developed using BEH C18 (2.1 X 50 mm) 1.7 µm column and gradient program for mobile phase. Mobile phase A contains 99% phosphate buffer of pH ~7.0 and 1% acetonitrile, whereas mobile phase B is the methanol and acetonitrile in 95:5 ratio. The 0.45 mL/min total flow rate, 3.0 µL injection volume, 40°C column oven temperature and 284 nm detection wavelength are used with sampling rate of 5 points per second. The DEX•Na peak is well separated from its known and unknown impurities. The...
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关键词翻译
关键词翻译
  • Rapid 拉皮德牌照相机
  • accurate 精确的
  • unknown 不知道的
  • robustness 坚固性
  • gradient 倾斜度
  • acetonitrile 乙腈
  • mobile 可动的
  • respect 珍视
  • points 
  • precise 精密的