HPLC法测定倍他米松及其乳膏的含量及有关物质___
RP-HPLC Determination Assay and its related substances of Betamethasone and betamethasone cream
分类号：
出版年·卷·期（页码）：2009,29 (12):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
目的:建立了HPLC法测定倍他米松及其乳膏的含量及有关物质。方法：色谱柱为Agilent C18 柱(4.6mm ×250mm，5μm)，流动相:乙腈-水（25:75），检测波长240nm，流速：1.8mL•min-1，柱温：45°C。结果：倍他米松在0.2～80µg.mL-1浓度范围内呈良好线性关系(r=0.99999)；倍他米松乳膏的平均回收率为100.3％，RSD=0.37％(n=9)。结论：该方法快速、简便、准确、灵敏、重现性好,并能有效地控制药品质量。
-----英文摘要：---------------------------------------------------------------------------------------
Objective: To establish an HPLC method for determination of assay and its related substances of betamethasone and betamethasone cream .Method:AnAgilent ODS (4.6 mm×250 mm，5µm)column was adopted with a mobile phase of a mixture of acethane-water (25:75)at a flow rate of 1.8 mL.min-1 and UV detector wavelength at 240 nm,Column tempreture was 45°C.Results:The average recovery of betamethasone (n=9) was 100.3% with RSD% 0.37%,The liner ranges of betamethasone was 0.2～80µg.mL-1 (r=0.9999).Conclusion:This method is rapid,simple,accurate,sensitive,it can be used for the control of quality of betamethasone and betamethasone cream.
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参考文献
1 New Edition Pharmacology.(新编药物学). 14en Ed(第14版).Beijing(北京):People Health Publishing House(人民卫生出版社),1997.424
2 BP.2007.267，2459
3 USP.31.1515
4 JP.15.355
5 ChP(中国药典).二部（Vol II）：620
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