Muhammad Ranjha Nazar, Rashid Zermina, Razzaq Rabia, Raza Hina, Hanif Muhammad, Mahmood Asif
Acta Pol Pharm. 2017 Mar;74(2):385-391.
The present study focused to develop rapid, accurate and sensitive reversed-phase high pressure liquid chromatography method for the quantification of esomeprazole (ESO) magnesium in rabbit plasma. Chromatographic separation was achieved isocratically on a reversed-phase C,, column using simple mobile phase consisting of of methanol : acetonitrile: 0.05 M phosphate buffer, pH 7 adjusted with potassium hydroxide (45 : 10 : 45, v/v/v) at a flow rate of 1.0 mL/min and UV detection at 302 nm. The method was validated for system suitability, linearity, precision, accuracy, stability, robustness, LOD and LOQ. The described method stated good linearity over the range of 0.01 to 2.5 pg/mL (r = 0.999). The extraction recovery of esomeprazole was more than 95.3%. The method was precise with relative standard deviation < 1% with more than 90% accuracy and limit of quantification 0.0309 μg/mL. The freeze thaw stability studies indicated that the rabbit plasma samples containing esomeprazole could be stored in freezer at -20⁰C and handled under normal laboratory conditions without significant loss of drug. In conclusion, the developed method is simple, cost effective and reproducible, with improved sensitivity and running time of analysis.
本研究致力于开发一种快速、准确且灵敏的反相高效液相色谱法，用于定量测定兔血浆中的埃索美拉唑镁。采用简单的流动相，即甲醇：乙腈：用氢氧化钾调节pH至7的0.05M磷酸盐缓冲液（45:10:45，v/v/v），以1.0mL/min的流速在反相C，柱上进行等度色谱分离，并在302nm处进行紫外检测。该方法在系统适用性、线性、精密度、准确度、稳定性、稳健性、检测限和定量限方面进行了验证。所述方法在0.01至2.5pg/mL范围内具有良好的线性（r = 0.999）。埃索美拉唑的提取回收率超过95.3%。该方法精密度良好，相对标准偏差<1%，准确度超过90%，定量限为0.0309μg/mL。冻融稳定性研究表明，含埃索美拉唑的兔血浆样品可在-20⁰C的冷冻箱中储存，并在正常实验室条件下处理，药物无明显损失。总之，所开发的方法简单、成本效益高且可重现，具有更高的灵敏度和更短的分析运行时间。
