Tatar Ulu Sevgi
Istanbul University, Faculty of Pharmacy, Department of Analytical Chemistry, 34416, Istanbul, Turkey.
J Chromatogr Sci. 2012 Jul;50(6):494-8. doi: 10.1093/chromsci/bms034. Epub 2012 Apr 17.
A high-performance liquid chromatographic (HPLC) method is described for the determination of duloxetine hydrochloride in capsules. The method was based on pre-column derivatization with 4-chloro-7-nitrobenzo-2-oxa-1,3-diazole using the fluorimetric detection technique. Duloxetine hydrochloride was analyzed by HPLC using an Inertsil C18 column (5 μm, 150 × 4.6 mm) and mobile phase consisted of methanol and water (65:35, v/v). The fluorescence detector was adjusted at excitation and emission wavelengths of 461 and 521 nm, respectively. The linearity of the method was in the range of 10-600 ng/mL. Limits of detection and quantification were 0.51 and 1.53 ng/mL, respectively. The proposed method was successfully applied for determination of duloxetine hydrochloride in its pharmaceutical preparation. The results were in good agreement with those obtained using a reference method.
描述了一种用于测定胶囊中盐酸度洛西汀的高效液相色谱（HPLC）方法。该方法基于使用4-氯-7-硝基苯并-2-恶唑-1,3-二唑进行柱前衍生化，并采用荧光检测技术。采用Inertsil C18柱（5μm，150×4.6mm）通过HPLC分析盐酸度洛西汀，流动相由甲醇和水（65:35，v/v）组成。荧光检测器的激发波长和发射波长分别调至461nm和521nm。该方法的线性范围为10 - 600 ng/mL。检测限和定量限分别为0.51 ng/mL和1.53 ng/mL。所提出的方法成功应用于其药物制剂中盐酸度洛西汀的测定。结果与使用参考方法获得的结果高度一致。
