摘要
目的:建立高效液相色谱法测定去甲斑蝥酸钠注射液含量及有关物质。方法:色谱柱为 YWG-C_(18)(4.6 mm×250 mm,5 μm),流动相为0.025 mol·L^(-1)磷酸二氢钾溶液-甲醇(75:25,磷酸调 pH 3.0),检测波长为210 nm。结果:含量测定方法的平均回收率为100.2%(n=9),线性范围为0.10～1.60 mg·mL^(-1)(r=0.9999);有关物质的检测限为0.16 ng(S/N=3),线性范围2.03～16.24μg·mL^(-1)(r=0.9986)。结论:该方法简便,结果准确,适用于去甲斑蝥酸钠注射液的质量控制。
Objective ：To establish an HPLC method for determination of sodium norcantharidate injection and its related substances. Methods：Using a YWG - C18 column （4. 6 mm × 250 mm,5μm） , the mobile phase consisted of 0. 025 mol · L^-1 potassium dihydrogen phosphate -methanol（75：25 ,adjusted to pH 3.0 with phosphoric acid）. The detection was carried out with a UV detector at 210 nm. Results ：The sodium norcantharidate curves were linear between 0. 10 and 1.60 mg · mL^-1 （r = 0. 9999）, the average recovery was 100. 2% （n = 9）. In the related substances examination, the calibration curve was linear in the range of 2. 03 - 16.24 μg · mL^- 1 （r = 0. 9986） , the detective limit was 0. 16 ng （ S/N= 3 ）. Conclusion： This method is convenient and accurate.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2007年第6期893-895,共3页
Chinese Journal of Pharmaceutical Analysis
基金
国家自然科学基金(20672069)
