以高效能液相層析法檢測痤瘡局部外用藥品之五種主成分

A High Performance Liquid Chromatography Method for Determination of Five Active Ingredients for Topical Acne Vulgaris Drugs

方經濃(Jing-Nung Fang)

指導教授 ： 吳寶珠

高雄醫學大學/藥學院/藥學研究所碩士在職專班/碩士(2014年)

https://doi.org/10.6832/KMU.2014.00023

摘要

痤瘡是一種常見的皮膚病問題，其治療可以使用全身性或局部性的藥物治療。局部外用製劑的主成分有clindamycin phosphate, benzoyl peroxide, tretinoin, isotretinoin 和adapalene 等，這些是最常使用在痤瘡治療的局部外用藥品主成分。本研究擬開發同時分析五種成分之分析方法，可應用在偵測外用製劑的抗痘活性成分。此外，本測試方法也可以用來檢測化妝品中藥物的非法添加。使用高效液相層析儀以及光電二極體陣列檢測器。所使用的管柱是C-18 的管柱，而移動相部分使用梯度沖提模式，共有三種移動相包括: （A） pH 2.5 之0.05 M磷酸氫鉀緩衝液 : 乙腈 = 75 : 25，（B）乙腈 : 水 : 冰醋酸 = 75 : 25 : 0.1，（C）四氫呋喃。移動相流速設定在每分鐘1.2 ∼ 1.5 毫升，而管柱溫度設定在攝氏35 度，檢測波長設定為210 nm (clindamycin phosphate), 270 nm (benzoyl peroxide), 360 nm (tretinoin)和320 nm (adapalene)。結果顯示檢測方法的專一性、準確度(recovery: 98~104%)、精密度(RSD% ≤ 2.0)、中間精密度(RSD% ≤ 2.0)、線性(R2 = 0.9974~0.9997)及耐變性(RSD% ≤ 2.0)都有不錯的表現，且在檢測市售品時也均能檢測出其產品主成分之含量(94.99~109.55%)。
關鍵字: 痤瘡、高效液相層析、外用製劑、clindamycin phosphate、benzoyl peroxide、tretinoin、isotretinoin、adapalene

關鍵字

痤瘡 ； 高效液相層析 ； 外用製劑 ； clindamycin phosphate ； benzoyl peroxide ； tretinoin ； isotretinoin ； adapalene

並列摘要

Acne vulgaris is a common dermatologic problem which could be treated with systemic or topical drugs. Clindamycin phosphate, benzoyl peroxide, tretinoin, isotretinoin and adapalene are the most common used ingredients in topical acne vulgaris treatment. This study is to develop an analytical method to determine these active ingredients in topical drugs at the same time. Furthermore, the analytical method can be also used to detect the illegal agents added in the cosmetic products. A high performance liquid chromatography method with photodiode array detector was used for the analysis. The determination was performed on a C-18 column by gradient elution with (A) pH 2.5, 0.05 M potassium hydrogen phosphate buffer : acetonitrile = 75 : 25, (B) acetonitrile : water : glacial acetic acid (75 : 25 : 0.1), (C) tetrahydrofuran. The HPLC system was operated at a flow rate of 1.2 ~ 1.5 mL/min and column temperature was set at 35 °C. The wavelength of photodiode array detector was set at 210 nm for clindamycin phosphate, 270 nm for benzoyl peroxide, 360 nm for tretinoin and isotretinoin, and 320 nm for adapalene. The result showed that the specificity of this method is good, and accuracy (recovery: 98~104%), precision (RSD% ≤ 2.0), intermediate Precision (RSD% ≤ 2.0), linearity (R2 = 0.9974~0.9997), robustness (RSD% ≤ 2.0) results are also suitable. For marketed products, active ingredients are also detected by this method (assay value:
94.99~109.55%).
Keywords: Acne vulgaris, HPLC, topical drug, clindamycin phosphate, benzoyl peroxide, tretinoin, isotretinoin, adapalene

並列關鍵字

acne vulgaris ； HPLC ； topical drug ； clindamycin phosphate ； benzoyl peroxide ； tretinoin ； isotretinoin ； adapalene

參考文獻

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