RP-HPLC法测定复方倍他米松注射液有关物质

RP-HPLC determination of related substances of compound betamethasone injection

目的:建立复方倍他米松注射液有关物质的反相高效液相色谱测定方法。方法:采用 Diamonsil^(TM)C_(18)ODS(5 μm,4.6mm × 250 mm)色谱柱,以0.05 mol·L^(-1)磷酸二氢钾-甲醇为流动相梯度洗脱60 min;检测波长254 nm,流速1.0 mL·min^(-1),柱温为35℃。结果:倍他米松磷酸钠最低检测限为0.4 ng,二丙酸倍他米松最低检测限为0.2 ng。结论:本方法简便,快速,准确,可用于复方倍他米松注射液有关物质的测定。

Objective：To establish RP-HPLC method for the determinationd related substances of Compound Betamethasone Injection. Method：DiamonsilTM C18 ODS column （5 μm,4.6 mm×250 mm） at 35℃. Mobile phase consisted of 0. 05 mol·mL^-1 monobasic potassium phosphate solution-methanol, gradient elution post time was 60 min. Detection wavelength was 254 nm, Flow rate was 1.0 mL·min^-1. Results： The LOD of betamethasone so-dium phosphate 0.4 ng, The LOD of betamethasone dipropionate 0.2 ng. Conclusion：The method is simple, rapid suitable for determination of the related substances of Compound Betamethasone Injection.