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Determination of dexamethasone acetate in CETETH 20‐based in liquid crystalline systems using HPLC
Biomedical Chromatography ( IF 1.8 ) Pub Date : 2020-12-13 , DOI: 10.1002/bmc.5054
Márcia Helena Oyafuso 1 , Bruno Fonseca-Santos 1 , Ana Carolina Kogawa 2 , Flávia Chiva Carvalho 1 , Maria Palmira Daflon Gremião 1 , Marlus Chorilli 1
Affiliation  

Dexamethasone acetate (DEX), a potent anti‐inflammatory, is used primarily in the treatment of inflammatory and autoimmune diseases. It was incorporated in CETETH 20 (polyoxyethylene 20 cetyl alcohol)–based liquid crystalline systems to enhance the purpose of the drug. Concomitant with the pharmaceutical technology performed, a HPLC method was developed and validated for the quantification of dexamethasone acetate in CETETH 20‐based liquid crystalline systems for the evaluation of the drug in the new matrix. The method was performed using a C18 column with acetonitrile:methanol:water (35:35:30, v/v/v) as the mobile phase at a flow rate of 0.8 mL min−1 at 239 nm. The method was linear in the range of 1–25 μg mL−1; the limit of quantification and limit of detection were 0.05 and 0.16 μg mL−1, respectively; the accuracy of the method was 99.92% (relative standard deviation < 1%), and it presented intra‐day and inter‐day precision with deviations less than 1%. In this context, the method was successfully used to determine the incorporation efficiency of DEX in CETETH 20‐based liquid crystalline systems and can be easily used by pharmaceutical companies and laboratories around the world.

中文翻译:

使用HPLC测定液晶系统中CETETH 20基中的醋酸地塞米松

醋酸地塞米松(DEX)是一种有效的抗炎药,主要用于治疗炎症和自身免疫性疾病。它被并入基于CETETH 20(聚氧乙烯20鲸蜡醇)的液晶系统中,以增强药物的用途。伴随着所采用的制药技术,开发了一种高效液相色谱法,并通过该方法对基于CETETH 20的液晶系统中醋酸地塞米松的定量进行了验证,以评估新基质中的药物。该方法使用C18色谱柱,以乙腈:甲醇:水(35:35:30,v / v / v)作为流动相,在239 nm处的流速为0.8 mL min -1进行。该方法在1–25μgmL -1范围内是线性的; 定量限和检测限分别为0.05和0.16μgmL -1;该方法的准确度为99.92%(相对标准偏差<1%),并且表现出日内和日间精度,偏差小于1%。在这种情况下,该方法已成功用于确定DEX在基于CETETH 20的液晶系统中的掺入效率,并且可以被全世界的制药公司和实验室轻松使用。
更新日期:2020-12-13
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