HPLC法测定右倍他米松磷酸钠注射液有关物质及含量(1)
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[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(250 mm×4.6 mm，5 μm)；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-0.05 mol/L磷酸二氢钾溶液(1∶1)；流速为0.8 ml/min，检测波长为254 nm，柱温为25℃，进样量为20 μl。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20.0～60.0 μg/ml(r=0.999 8)，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。
[关键词] HPLC；右倍他米松磷酸钠注射液；有关物质；含量测定
[中图分类号]R927 [文献标识码]A [文章编号]1673-7210(2009)06(c)-057-04
Content determination of Dexbetamethasone Sodium Phosphate Injection and its related substances by HPLC
HE Ling1, LI Jianhe2, PENG Liubao2, CAO Junhua2, LUO Xia2
(1.Department of Pharmacy, People's Hospital of Xiangxi Autonomous Perfecture, Jishou 416000, China; 2.Department of Pharmacy, the Second Xiangya Hospital, Central South University, Changsha410011, China)
[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.
[Key words] HPLC; Dexbetamethasone Sodium Phosphate Injection; Related substance; Content determination
右倍他米松磷酸钠是一种人工合成的长效糖皮质激素类药物，为地塞米松的差向异构体，最早由美国Priter公司、英国Giaxo公司研制上市，近年来国内也研制成功，生产工艺已达到国外同等水平。本品具有抗过敏、抑制免疫等多种药理作用[1]；其抗过敏作用较地塞米松略强 ......
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