琥珀酸舒马普坦片剂剂型定量核磁共振波谱法的研制与验证

Mangarao Nakka
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引用次数: 1

摘要

建立了一种简便、准确的质子核磁共振(qNMR)定量测定片中琥珀酸舒马普坦含量的新方法。在本发明的定量核磁共振波谱法中,由于与被分析物峰不重叠,以马来酸为内标,以氧化氘(D2O)为稀释剂。琥珀酸舒马匹坦的定量以4.43 ppm和6.20 ppm的峰为定量监测目的,分别对应分析物琥珀酸舒马匹坦和马来酸内标。最终优化的方法按照国际激素会议(ICH)指南在特异性、检出限(LOD)、定量限(LOQ)、精密度、线性、准确性、溶液稳定性和鲁棒性方面进行了验证。该方法可用于琥珀酸舒马匹坦散装和片剂的含量测定。
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QUANTITATIVE NUCLEAR MAGNETIC RESONANCE SPECTROSCOPIC METHOD DEVELOPMENT AND VALIDATION OF SUMATRIPTAN SUCCINATE IN PHARMACEUTICAL TABLET DOSAGE FORM
A new, simple and accurate quantitative proton nuclear magnetic resonance(qNMR) spectroscopic  method was developed to determine the sumatriptan succinate in pharmaceutical tablet formulation. In this developed quantitative nuclear magnetic resonance spectroscopy method,Maleic acid was used as internal standard(IS) due to there was no overlapping of the peak  to analyte peaks and deuterium oxide(D2O) was used as diluent. For the quantification of the sumatriptan succinate 4.43 ppm and 6.20 ppm  peaks were used as quantitative monitoring purpose to correspong to analyte sumatriptane succinate and Maleic acid internal standard(IS) respectively. The final optimized  method was validated as per International Conference on Hormonisation (ICH) guidelines in terms  of Specificity, Limit of detection (LOD), Limit of Quantitation (LOQ), Pecision, Linearity, Accuracy ,Solution stability and Robustness. This method could be used to determination of sumatriptane succinate  in bulk and  pharmaceutical  tablet dosage forms.
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