以高效能液相層析法改善環索奈德分析方法

Method Improvement for Ciclesonide Analysis by High Performance Liquid Chromatography

葉沛妤(Pei-Yu Yeh)

指導教授 ： 曾博修

中山醫學大學/醫學院/生化微生物免疫研究所/碩士(2019年)

https://doi.org/10.6834/CSMU201900063

摘要

Ciclesonide(環索奈德)為一種皮質類固醇，用於預防與減輕哮喘、過敏性鼻炎引起的症狀，減少肺部呼吸道的腫脹，有助於減輕發炎症狀。Ciclesonide的分析方法一般採用英國及歐洲藥典的記載，其移動相乃為無水乙醇和純水以62:38的比例進行配製，然而分析過程中發現Ciclesonide的波峰分離效果與波形並不理想，且因基線干擾度增加導致積分不穩定，影響積分面積造成誤判。
本篇論文針對Ciclesonide的分析方法進行改善：(1)以磷酸二氫鈉(NaH2PO4)緩衝溶液：乙腈＝28：72作為移動相，(2)流速1.5mL/min，(3)管柱使用Hypersil C18, 5µm, 4 mm x 125 mm，(4)檢測波長245nm，(5)管柱溫度35℃，(6)注射體積70ul，依循ICH指導原則進行驗證，發現Ciclesonide滯留時間落在3.73min ± 0.3，線性檢測濃度在6 ~ 14 ug/mL範圍內呈現良好的線性關係(R2 = 0.9999)，皆優於英國及歐洲藥典方法分析結果。因此本篇論文提出更高效率的高效液相性層析方法來分析Ciclesonide。

關鍵字

環索奈德

並列摘要

Ciclesonide is a corticosteroid, used to prevent and alleviate the symptoms caused by asthma and allergic rhinitis, to reduce the swelling of the respiratory tract of the lungs, and help to reduce inflammation. Ciclesonide analytical method is generally described in the British and European Pharmacopoeia, where the mobile phase is prepared using anhydrous ethanol and pure water at the ratio of 62:38. However, the peak separation effect and waveform of Ciclesonide are not ideal during the analysis. The increase in baseline interference leads to unstable integration, which affects the integral area and causes misjudgment.
In this thesis, the analytical method of Ciclesonide is improved as followed (1) sodium dihydrogen phosphate (NaH2PO4) buffer solution: acetonitrile = 28:72 as mobile phase, (2) flow rate 1.5mL / min, (3) Hypersil C18, 5μm, 4 mm x 125 mm as the column, (4) 245nm as detection wavelength, (5) 35 °C as column temperature, (6) 70

並列關鍵字

Ciclesonide,

參考文獻

[1] OMNARIS Nasal Spray 50mcg (Ciclesonide) 衛署藥輸字第025204 號說明書

[2] European Pharmacopoeia Commission, & European Directorate for the Quality of Medicines & Healthcare, European pharmacopoeia. Council of Europe, 2013, 1879-1880.

[3] British Pharmacopoeia Commission Secretariat, part of the Medicines and Healthcare products Regulatory Agency.

[4] Dent, G. (2002). Ciclesonide (Byk Gulden). Current opinion in investigational drugs (London, England: 2000), 3(1), 78-83.

[5] “保衛康”治喘樂吸入劑80微公克衛署藥輸字第024786號說明書