摘要
目的 :建立丹曲林钠的质量控制方法。方法 :高效液相色谱法。ZorbaxC8柱 ,甲醇 -乙腈 -水 (2 5 0∶2 5 0∶5 0 0 )为流动相 ,流速 1 0mL·min- 1 ,检测波长 315nm。结果 :丹曲林钠与共存的杂质达很好分离。丹曲林钠在 0 0 8～ 0 4mg·mL- 1 范围内 ,峰面积与浓度呈线性关系 ,r=0 9999。平均回收率为 99 9% (RSD为 0 85 % )。结论 :该方法可用于丹曲林钠的含量测定及共存杂质的检查。
Objective:To develop a method for assay of dantrolene sodium.Method:A HPLC method was developed.Chromatographic conditions included Zorbax C 8 column and the mobile phase is methanol-acetonitrile-water(250∶250∶500).The UV detection wavelength was at 315 nm.Results:A satisfactory separation among dantrolene sodium and related impurities was obitaned.The calibration curve was liner in the range of 0.08～0.4 mg·mL -1 for dantrolene sodium The average recovery of dantrolene sodium was 99.9%(RSD=0.85%).Conclusion:This method could be used for the determination of dantrolene sodium.It could also be used for the impurity test of dantrolene sodium.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2001年第3期163-164,共2页
Chinese Journal of Pharmaceutical Analysis
