Development and Validation of a Quantitative NMR Method for the Determination of the Commercial Tablet Formulation of Sulfasalazine

被引:4
|
作者
Su, Feng [1 ,2 ]
Sun, Zi-qing [1 ,2 ]
Liang, Xian-Rui [1 ,2 ]
机构
[1] Zhejiang Univ Technol, Coll Pharmaceut Sci, Minist Educ, Key Lab Green Pharmaceut Technol & Related Equipm, Hangzhou 310014, Zhejiang, Peoples R China
[2] Zhejiang Univ Technol, Collaborat Innovat Ctr Yangtze River Delta Reg Gr, Natl Engn Res Ctr Proc Dev Act Pharmaceut Ingredi, Hangzhou 310014, Zhejiang, Peoples R China
基金
中国国家自然科学基金;
关键词
NMR; qNMR; sulfasalazine; method validation; commercial tablet formulation; pharmaceutical analysis; SPECTROSCOPY; SPECTROMETRY; H-1;
D O I
10.2174/1573412913666170707113548
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Introduction: Quantitative NMR spectroscopy (qNMR) is a rapid, simple and efficient method for the assay of sulfasalazine (SSZ) in commercial tablet formulation. Materials and Methods: The qNMR method was demonstrated using maleic acid as an internal standard and DMSO-d(6) as a solvent. The characteristic signals of SSZ at delta 8.36 ppm and maleic acid at delta 6.28 ppm were quantified. The reliability of the quantification method had been implemented successfully in validated experiments including specificity and selectivity, linearity, recovery, precision concentration rang, limit of detection (LOD), limit of quantification (LOQ), stability and robustness. Conclusion: The method was found to be liner (R-2 = 0.9991) from 8.62 to 20.14 mg/0.6 mL DMSO-d(6) in the drug concentration range. The maximum relative standard deviation (RSD) of recovery and precision were tested to be 0.59% and 0.65%, respectively. The LOD and LOQ were determined to be 0.02, 0.07 mg/mL, respectively. The RSD of stability was 0.05%. The robustness was demonstrated by changing four different parameters with the maximum difference less than 0.9%. In addition, the result of qNMR showed in good agreement with the HPLC and UV methods. Based on the experiments, the developed method was successfully applied to the determination of SSZ in commercial tablet.
引用
收藏
页码:39 / 44
页数:6
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