Determination of fluticasone propionate in raw materials and nasal sprays by UPLC-MS/MS
Objective:To establish a UPLC method for the determination of fluticasone propionate in fluticasone propionate raw materials and nasal sprays,which can be used to qualitatively identify the impurities of fluticasone propionate.Methods:The analytes were separated on a HALO90Å,C18 column(100mm×2.1mm,2.7 μm)using a gradient elution with the mobile phase of acetonitrile-0.1%formic acid(containing 0.1%ammonium acetate).The flow rate was 0.3 mL·min-1,the column temperature was 40℃,and the detection wavelength was 239 nm.The impurities of fluticasone propionate were qualitatively identified by UPLC-MS/MS under an ESI positive mode.Results:The chromatographic peak for the principal component of fluticasone propionate was well separated from each impurity.The linearity range of fluticasone propionate was0.5～50.0μg·mL-1(R2 =0.9998),and the recovery of fluticasone propionate nasal spray was 95.51%(RSD =1.59%,n =9).The percentage of fluticasone propionate in the raw material was 99.54%,the percentage of labeled amount of three batches of fluticasone propionate nasal spray were 96.69%,98.32%and 96.00%,respectively.Conclusion:The method,which is rapid,simple and sensitive,can be used for the quantitative determination of fluticasone propionate in raw materials and the nasal spray,as well as the qualitative identification of the impurities.
NETL
NSTL
万方数据
维普
