{"title":"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","authors":"Mangarao Nakka","doi":"10.20902/ijctr.2018.110502","DOIUrl":null,"url":null,"abstract":"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.","PeriodicalId":13780,"journal":{"name":"International Journal of Chemical and Pharmaceutical Analysis","volume":"5 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"QUANTITATIVE NUCLEAR MAGNETIC RESONANCE SPECTROSCOPIC METHOD DEVELOPMENT AND VALIDATION OF SUMATRIPTAN SUCCINATE IN PHARMACEUTICAL TABLET DOSAGE FORM\",\"authors\":\"Mangarao Nakka\",\"doi\":\"10.20902/ijctr.2018.110502\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"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.\",\"PeriodicalId\":13780,\"journal\":{\"name\":\"International Journal of Chemical and Pharmaceutical Analysis\",\"volume\":\"5 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2017-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Chemical and Pharmaceutical Analysis\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.20902/ijctr.2018.110502\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Chemical and Pharmaceutical Analysis","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.20902/ijctr.2018.110502","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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.