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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nifdc.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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拉曼光谱法测定氯膦酸二钠注射液的含量

Quantitative determination of clodronate disodium injection by Raman spectroscopy

分类号:
出版年·卷·期(页码):2014,34 (2):0-0
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的:建立拉曼光谱法测定氯膦酸二钠注射液的含量的方法。方法:利用拉曼散射原理,在水溶液中,拉曼峰信号的强度与溶质分子的浓度成正比,选取样品溶液拉曼光谱中氯膦酸二钠的P=O基团振动(1079 cm-1)处的强峰作为定量峰,建立拉曼光谱法测定氯膦酸二钠注射液含量的方法。结果:氯膦酸二钠在2~100 mg·mL-1范围内与拉曼峰强度呈良好的线性关系,线性回归方程为Y=426.0X+286.6,相关系数为0.9999(n=8),平均回收率为102.8%,RSD为1.6%(n=9)。结论:本方法操作简便、快速,可用于氯膦酸二钠注射液的含量测定。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To establish a Raman method for the determination of clodronate disodium injection. Methods: Based on the Raman scattering theory that the light intensity of the laser Raman peak is in proportional to the concentration of clodronate disodium samples in aqueous solution, a quantitative method for determination of clodronate disodium injection using Raman spectroscopy was established by selecting the Raman peak of clodronate disodium P=O bond (P=O[1079 cm-1]) as the quantitative peak. Results: The calibration curve was linear over the range of 2-100 mg·mL-1 (r= 0.9999,n=8),and the average recovery was 102.8% with RSD of 1.6% (n=9). Conclusion: The method is convenient and rapid,which can be used for the quality control of clodronate disodium injection.

-----参考文献:---------------------------------------------------------------------------------------
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[3] FENG Jin-yuan(冯金元), HE Yan(何燕).Analysis of disodium clodronate injection by ion-exchange chromatography with post-column derivatization(柱后衍生离子色谱法测定氯膦酸二钠注射液的含量)[J].J Guangdong Coll Pharm(广东药学院学报), 2006, 22(5):516, 523
[4] Prutthiwanasan B, Suntornsuk L.Rapid analysis of alkylphosphonate drugs by capillary zone electrophoresis using indirect ultraviolet detection[J].J Sep Sci, 2010, 33(2):228
[5] Koba M, Koba K, Przyborowski L.Application of UV-derivative spectrophotometry for determination of some bisphosphonate drugs in pharmaceutical formulations[J].Acta Polon Pharm, 2008, 65(3):289
[6] LEI Yi(雷毅), ZHONG Xin-lin(钟新林).Determination of clodronate disodium and its related substances in its preparations by ion chromatography(离子色谱法测定氯膦酸二钠及其制剂的含量和有关物质)[J].Chin J Anal Chem(分析化学), 2009, 37(7):1065
[7] ChP 2010.Vol Ⅱ(中国药典2010年版.二部)[S].2010:1034
[8] ZHANG Tian-ying(张天英), LI Hong-ying(李洪影), GUO Yu-zhi(国玉芝), et al.Observational study on the basic characters and stability of disodinum clodronate(氯磷酸二钠基本性质及稳定性考察研究)[J].Chin Med Rec(中国病案), 2013, 14(4):52

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