摘要
目的 结合生产工艺及所用物料,分析美索巴莫的杂质谱,并对杂质进行控制。方法 采用高效液相色谱法(HPLC)、气相色谱法(GC)分别对美索巴莫的有机杂质、挥发性杂质进行测定。结果 有机杂质1、2、4在1~8 μgmL-1内呈现良好的线性关系(r>0.999 3),回收率分别为101.6%(RSD为3.4%)、104.9%(RSD为2.0%)、106.3%(RSD为3.3%);挥发性杂质甲醇、乙酸乙酯、碳酸二甲酯与甲苯相邻峰间的分离度及检测灵敏度均符合要求。结论 HPLC、GC简便、快速、结果准确可靠,可用于美索巴莫的杂质控制。
Abstract
OBJECTIVE To identify and analyze the potential impurities of methocarbamol on the basis of its synthetic route and starting materials.METHODS Related substances of methocarbamol were determined by HPLC, and volatile organic impurities were determined by GC. RESULTS The linear responses range were from 1 to 8 μgmL-1 for impurity 1, 2, and 4. The average recoveries of impurity 1, 2, and 4 were 101.6% (RSD 3.4%), 104.9% (RSD 2.0%), and 106.3% (RSD 3.3%), respectively. Four volatile organic impurities were separated completely by GC, and the resolution and sensitivity were acceptable. CONCLUSION TheMETHODS were proved to be simple, accurate, rapid and reliable, which can be used for impurity control of methocarbamol.
关键词
美索巴莫 /
杂质谱 /
杂质控制 /
愈创木酚甘油醚 /
4-(2-甲氧基苯氧甲基)-1 /
3-二氧戊环-2-酮
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Key words
methocarbamol /
impurity profile /
impurity control /
guaifenesin /
4-(2-methoxyphenoxymethyl)-1,3-dioxolan-2-one
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楼永军,陈爽,李煜,郑国钢.
美索巴莫杂质控制的研究[J]. 中国药学杂志, 2014, 49(18): 1648-1651 https://doi.org/10.11669/cpj.2014.18.017
LOU Yong-jun,CHEN Shuang,LI Yu,ZHENG Guo-gang.
Impurity Control of Methocarbamol[J]. Chinese Pharmaceutical Journal, 2014, 49(18): 1648-1651 https://doi.org/10.11669/cpj.2014.18.017
中图分类号:
R917
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参考文献
[1] LING D K. Related impurities and high performance liquid chromatography[J]. Chin Pharm J(中国药学杂志), 2000, 35(8):567-569.[2] HU C Q. Current situation and the trend in impurity control of chemical drugs[J]. Sci Sin Chim(中国科学: 化学), 2010, 40(6):679-687.[3] CARPENTER, EARNEST B. Methocarbamol as a muscle relaxant-its clinical evaluation in acute trauma and chronic neurological states [J]. South Med J, 1958, 51(5): 627-630.[4] PARK, HERBERT W. Clinical results with methocarbamol, a new interneuronal blocking agent [J]. JAMA, 1958, 167(2): 168-172.[5] USP33(美国药典33版)[S]. 2010: 2925-2926.[6] ZHOU H J. ICH(药品注册的国际技术要求)[M]. Quality Part. Beijing: People's Medical Publishing House, 2011: 16.[7] Ch.P(2010) Vol Ⅱ(中国药典2010年版,二部)[S]. 2010: Appendix ⅪⅩ C: 199-201.
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脚注
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