HPLC法测定地塞米松磷酸钠注射液中地塞米松磷酸钠含量  

Determination of Dexamethasone Sodium Phosphate in Dexamethasone Sodium Phosphate Injection by HPLC

作　　者：张立江 王琨 Zhang Lijiang;Wang Kun(Sinopharm Rong Sheng Pharmaceutical Co.,Ltd.,Jiaozuo 454950,China)

机构地区：[1]国药集团容生制药有限公司,河南焦作454950

出　　处：《云南化工》2023年第2期94-96,共3页Yunnan Chemical Technology

摘　　要：建立了高效液相色谱法测定地塞米松磷酸钠注射液中地塞米松磷酸钠的含量。采用Kromasil C_(8)(4.6 mm×150 mm,5μm),流动相为三乙胺溶液(取三乙胺7.5 mL,加水稀释1000 mL,用磷酸调节pH值至3.0)-甲醇-乙腈(55∶40∶5),流速1.5 mL/min,检测波长242 nm,柱温30℃,进样体积20μL。结果表明,线性范围,0.0159~0.0557 mg/mL,r=1.00000;精密度试验,峰面积RSD为0.04%;重复性试验,6份样品平均含量为102.400%,RSD为0.12%;回收率试验,平均回收率为99.5%,RSD为0.70%。该法准确可靠,重现性良好,可作为地塞米松磷酸钠注射液中地塞米松磷酸钠含量检测方法。To establish a High-performance liquid chromatography method for the determination of dexamethasone sodium phosphate in dexamethasone sodium phosphate injection.Kromasil C_(8)(4.6×150 mm,5μm),the mobile phase is triethylamine solution(7.5 mL triethylamine,diluted 1000 mL with water,adjusted pH to 3.0 with phosphoric acid)-methanol-acetonitrile(55∶40∶5);Flow rate is 1.5mL/min,detection wavelength is 242 nm,column temperature is 30℃,injection volume is 20μL withlinear range of 0.0159~0.0557 mg/mL,r=1.00000;In precision test,RSD of peak area is 0.04%.The average content of 6 samples was 102.4%,RSD is 0.12%;The average recovery is 99.5%,RSD is 0.70%.Conclusion:the method is accurate,reliable and reproducible.It can be used for the determination of dexamethasone sodium phosphate in dexamethasone sodium phosphate injection.

关 键 词：高效液相色谱法 地塞米松磷酸钠注射液 地塞米松磷酸钠 

分 类 号：TQ460.72[医药卫生—药物分析学]