HPLC-UV 法测定皮肤层中布地奈德含量的验证。
Validation of a HPLC-UV method for the quantification of budesonide in skin layers.
机构信息
Department of Food and Drug, University of Parma, Parco Area delle Scienze 27/a, 43124 Parma Italy.
Human and Natural Sciences Centre, Federal University of ABC, Av dos Estados 5001, Bloco A, Torre 3, CEP 09210-580. Santo André, SP, Brazil.
出版信息
J Chromatogr B Analyt Technol Biomed Life Sci. 2021 Feb 1;1164:122512. doi: 10.1016/j.jchromb.2020.122512. Epub 2020 Dec 24.
A simple and sensitive HPLC method for the quantification of budesonide in skin layers was developed and validated. Budesonide was extracted from stratum corneum, epidermis and dermis by means of a mixture of acetonitrile:water (recovery > 90%). Budesonide quantification was performed with a RP-C18 column using methanol and water mixture (69:31, v/v) as mobile phase, pumped at 0.8 ml/min. The absorbance was monitored at 254 nm. The method resulted to be selective, linear in the range 0.05-5 or 10 μg/ml, precise and accurate. LLOQ resulted to be 0.05 μg/ml. The developed method appeared to be appropriate for the quantification of budesonide in skin layers at the end of in vitro permeation experiments since the recovery of the applied dose was 97 ± 1%, in line with requirement of the OECD guideline for the testing of the chemicals (Skin absorption: in vitro method).
建立并验证了一种用于检测皮肤各层布地奈德含量的简单、灵敏的高效液相色谱法。采用乙腈-水（回收率>90%）混合液从角质层、表皮和真皮中提取布地奈德。采用反相 C18 柱，以甲醇和水混合液（69:31，v/v）为流动相，以 0.8ml/min 的流速进行洗脱，于 254nm 处进行检测。该方法选择性好，在 0.05-5 或 10μg/ml 范围内线性良好，精密度和准确度高。LLOQ 为 0.05μg/ml。该方法回收率为 97±1%，符合经合组织化学品测试指南（皮肤吸收：体外法）的要求，适用于体外透皮实验结束时对皮肤各层布地奈德含量的检测。
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