Ewelina Szalek, Boguslawa Musial, Kamila Czarnecka, Paweł Szymański
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引用次数: 0
摘要
维兰特罗(VT)和糠酸氟替卡松(FF)是最近在干粉吸入器(DPI)中使用的成分,用于哮喘或慢性阻塞性肺疾病(COPD)等呼吸系统疾病患者。在本研究中,提出了一种分析程序开发和验证的方法。采用新一代冲击器(NGI)和高效液相色谱法(HPLC)结合紫外检测器测定了DPI中两种化合物和各有效成分的细颗粒剂量(FPD)。在Poroshell SB C18 (100 mm × 4.6 mm, 2.7µm)柱上,采用磷酸盐缓冲液和乙腈梯度洗脱,获得了最满意的色谱分离效果。VT和FF分别在波长为210 nm和245 nm的紫外检测器上检测。在各种涂层剂中,选择4%聚乙二醇PEG 200在丙酮(w/v)中的效果最好。虽然VT和FF的物理化学性质各不相同,但分析过程允许在不同波长同时测定两种化合物。维兰特罗和糠酸氟替卡松的定量限分别为0.049µg/ml和0.032µg/ml,符合DPI中微量剂量有效成分FPD的测定要求。VT和FF的LOQ分别为- 2.5µg/ml和- 10.0µg/ml,分析方法线性准确。VT和FF的决定系数R2分别为0.9999和1.000。
Simultaneously determination of fine particle dose of vilanterol and fluticasone furoate for dry powder inhaler (DPI) by utilizing gradient elution in chromatography system
Vilanterol (VT) and fluticasone furoate (FF) are components recently used in dry powder inhaler (DPI) to be administrated for patients with respiratory diseases, such as asthma or chronic obstructive pulmonary disease (COPD). In the present study, an approach to an analytical procedure development and validation is presented. Next generation impactor (NGI) and high performance liquid chromatography (HPLC) with UV detector were applied to determine two compounds and fine particle dose (FPD) of each active ingredients in DPI. The most satisfying chromatographic separation was obtained on Poroshell SB C18 (100 mm × 4.6 mm, 2.7 µm) column applying gradient elution by phosphonate buffer and acetonitrile. VT and FF were detected on a UV detector at wavelength of 210 nm and 245 nm, respectively. Among various coating agents, 4% polyethylene glycol PEG 200 in acetone (w/v) was selected as the most effective. Although various physicochemical properties of VT and FF, the analytical procedure allows simultaneously determine two compounds at different wavelengths. Limit of quantitative (LOQ) of vilanterol and fluticasone furoate were determined as 0.049 µg/ml and 0.032 µg/ml, respectively, what is desirable to determine of FPD of active ingredients in microdoses in DPI. The analytical procedure was determined as linear and accurate in the range of LOQ – 2.5 µg/ml and LOQ – 10.0 µg/ml of VT and FF, respectively. The coefficient of determination (R2) was found to be 0.9999 and 1.000 for VT and FF, respectively.
期刊介绍:
The international journal of the Polish Pharmaceutical Society is published in 6 issues a year. The journal offers Open Access publication of original research papers, short communications and reviews written in English, in all areas of pharmaceutical sciences. The following areas of pharmaceutical sciences are covered: Analysis, Biopharmacy, Drug Biochemistry, Drug Synthesis, Natural Drugs, Pharmaceutical Technology, Pharmacology and General.
A bimonthly appearing in English since 1994, which continues “Acta Poloniae Pharmaceutica”, whose first issue appeared in December 1937. The war halted the activity of the journal’s creators. Issuance of “Acta Poloniae Pharmaceutica” was resumed in 1947. From 1947 the journal appeared irregularly, initially as a quarterly, then a bimonthly. In the years 1963 – 1973 alongside the Polish version appeared the English edition of the journal. Starting from 1974 only works in English are published in the journal. Since 1995 the journal has been appearing very regularly in two-month intervals (six books a year). The journal publishes original works from all fields of pharmacy, summaries of postdoctoral dissertations and laboratory notes.