【摘要】 目的:建立测定右倍他米松磷酸钠注射液有关物质及含量的HPLC法。方法:色谱柱为Hypersil ODS2柱(250mm×4.6mm,5μm);有关物质测定的流动相为磷酸二氢钾己胺溶液-乙腈(74∶26),含量测定的流动相为甲醇-0.05mol/L磷酸二氢钾溶液(1∶1);流速为0.8ml/min,检测波长为254nm,柱温为25℃,进样量为20μl。结果:3批样品中有关物质的平均含量为6.11%。右倍他米松磷酸钠检测浓度的线性范围为20.0～60.0μg/ml(r=0.9998),平均回收率为98.5%(RSD=0.89%)。结论:本检测方法灵敏、快速、结果准确,可用于右倍他米松磷酸钠注射液的质量控制。更多还原

【Abstract】 Objective: To establish an HPLC method for the determination of Dexbetamethasone Sodium Phosphate Injection and its related substances. Methods: The chromatographic separation was performed on a Hypersil ODS2 column(250 mm× 4.6 mm, 5 μm) with mobile phases of potassium dihydrogen phosphate hexyl amine solution-acetonitrile(74 ∶26) for the determination of its related substances and methanol-0.05 mol/L potassium dihydrogen phosphate solution(1 ∶1) for the determination of dexbetamethasone sodium phosphate. The flow rate was 0.8 ml/min, the detection wavelength was 254 nm, the column temperature was 25℃ and the sample size was 20 μl. Results: The average content of the related substances in three batches of samples was 6.11%. The linear range of dexbetamethasone sodium phosphate was 20.0-60.0 μg/ml(r= 0.999 8) and the average recovery was 98.5%(RSD=0.89%). Conclusion: The method is sensitive, accurate, rapid and can be used to the quality control of Dexbetamethasone Sodium Phosphate Injection.更多还原