Reddy Venkata Krishna, Swamy Narayana, Rathod Rajeswari, Sengupta Pinaki
Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad, Opposite Air Force Station, Palaj, Gandhinagar, Gujarat, India.
J Chromatogr Sci. 2019 Aug 1;57(7):600-605. doi: 10.1093/chromsci/bmz033.
A simple and sensitive bioanalytical HPLC-UV method has been developed and validated for quantification of eliglustat in rat plasma. The liquid-liquid extraction method was found to be more efficient compared to protein precipitation technique. Chromatographic separation of eliglustat was achieved using Kromasil C18 column with a mobile phase consisting of a mixture of methanol and ammonium acetate (pH 3.2) in a ratio of 60:40. Detection wavelength was set at 282 nm. The developed method was specific, accurate, precise with good recovery and stability profile. The calibration curve constructed over a range of 0.3-10 μg/mL was linear (R2 > 0.997). Accuracy in intra and inter-day assay were found to be 96.27-107.35% and 96.80-106.57%, respectively. The corresponding precision (%CV) values were within 4.31-10.90% and 4.82-9.97%, respectively. Till date, no method is available for bioanalysis of eliglustat in any type of biological matrix. This is the first time to report a bioanalytical method for this molecule. The developed bioanalytical method was applied to quantitate eliglustat in the plasma samples of a single dose oral pharmacokinetic study in Sprague Dawley rat.
已开发并验证了一种简单且灵敏的生物分析HPLC-UV方法，用于定量大鼠血浆中的依利格鲁司他。结果发现，与蛋白沉淀技术相比，液-液萃取法效率更高。使用Kromasil C18柱进行依利格鲁司他的色谱分离，流动相由甲醇和醋酸铵（pH 3.2）按60:40的比例混合而成。检测波长设定为282 nm。所开发的方法具有特异性、准确性、精密度，回收率良好且稳定性良好。在0.3-10 μg/mL范围内构建的校准曲线呈线性（R2>0.997）。日内和日间测定的准确度分别为96.27-107.35%和96.80-106.57%。相应的精密度（%CV）值分别在4.31-10.90%和4.82-9.97%范围内。迄今为止，尚无任何方法可用于任何类型生物基质中依利格鲁司他的生物分析。这是首次报道该分子的生物分析方法。所开发的生物分析方法应用于在Sprague Dawley大鼠单剂量口服药代动力学研究的血浆样品中定量依利格鲁司他。
