美索巴莫杂质控制的研究

Impurity Control of Methocarbamol

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1-8μg·mL^-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。

OBJECTIVE To identify and analyze the potential impurities of methocarbamol on the basis of its synthetic route and starting materials. METHODS Related substances of methoearbamol were determined by HPLC, and volatile organic impurities were determined by GC. RESULTS The linear responses range were from 1 to 8μg·mL^-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 The methods were proved to he simple, accurate, rapid and reliable, which can be used for impurity control of methocarbamol.