Stability-indicating micellar electrokinetic chromatography method for the analysis of sumatriptan succinate in pharmaceutical formulations

被引:21
作者
Al Azzam, Khaldun M. [1 ,2 ]
Saad, Bahruddin [1 ]
Tat, Chai Yuan [1 ]
Mat, Ishak [2 ]
Aboul-Enein, Hassan Y. [3 ]
机构
[1] Univ Sains Malaysia, Sch Chem Sci, George Town 11800, Malaysia
[2] Univ Sains Malaysia, Unit Kanser MAKNA USM, Adv Med & Dent Inst, George Town 11800, Malaysia
[3] Natl Res Ctr, Pharmaceut & Med Chem Dept, Cairo 12311, Egypt
关键词
Sumatriptan succinate; Micellar electrokinetic chromatography (MEKC); Capillary electrophoresis (CE); Reversed polarity; SOLID-PHASE EXTRACTION; CAPILLARY-ELECTROPHORESIS; VALIDATION; ASSAY; IMPURITIES;
D O I
10.1016/j.jpba.2011.08.007
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
A micellar electrokinetic chromatography method for the determination of sumatriptan succinate in pharmaceutical formulations was developed. The effects of several factors such as pH, surfactant and buffer concentration, applied voltage, capillary temperature, and injection time were investigated. Separation took about 5 min using phenobarbital as internal standard. The separation was carried out in reversed polarity mode at 20 degrees C, 26 kV and using hydrodynamic injection for 10 s. Separation was achieved using a bare fused-silica capillary 50 mu mx40 cm and background electrolyte of 25 mM sodium dihydrogen phosphate-adjusted with concentrated phosphoric acid to pH 2.2, containing 125 mM sodium dodecyl sulfate and detection was at 226 nm. The method was validated with respect to linearity, limits of detection and quantification, accuracy, precision and selectivity. The calibration curve was linear over the range of 100-2000 mu g mL(-1). The relative standard deviations of intra-day and inter-day precision for migration time, peak area, corrected peak area, ratio of corrected peak area and ratio of peak area were less than 0.68, 3.48, 3.28, 2.97 and 2.83% and 2.01, 5.50, 4.46, 4.92 and 4.07%, respectively. The proposed method was successfully applied to the determinations of the analyte in tablet. Forced degradation studies were conducted by introducing a sample of sumatriptan succinate standard solution to different forced degradation conditions using neutral (water), basic (0.1 M NaOH), acidic (0.1 M HCl), oxidative (10% H2O2) and photolytic (exposure to UV light at 254 nm for 2 h). It is concluded that the stability-indicating method for sumatriptan succinate can be used for the analysis of the drug in various samples. (C) 2011 Elsevier B.V. All rights reserved.
引用
收藏
页码:937 / 943
页数:7
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