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| DOI | 10.1016/j.jpba.2019.07.021 |
| Incorporating solid-phase extraction into compendial procedures for the determination of dexamethasone and impurities in low-dose drug products | |
| Xu, Qun | |
| 通讯作者 | Xu, Qun |
| 来源期刊 | JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
 |
| ISSN | 0731-7085 |
| EISSN | 1873-264X |
| 出版年 | 2019 |
| 卷号 | 175 |
| 英文摘要 | A low-dose drug product is characterized by extremely low concentrations of analytes and a high ratio of excipients to the drug substance; the analysis of these drug products presents a number of analytical challenges for detection and quantitation, which in turn could impact potency, purity, and uniformity of the dosage units. In this work solid-phase extraction (SPE) was used to enrich analytes and minimize the interference of excipients, despite the fact that the application of SPE to pharmaceutical dosage forms is surprisingly uncommon. Specifically, in the development of compendial procedures for two dexamethasone (DEX) low-dose drug products, elixir 0.1 mg/mL and oral solution 0.1 mg/mL, a SPE protocol using Oasis HLB cartridges was developed for sample preconcentration and clean-up. The protocol was rigorously evaluated to ensure high recoveries and repeatability for DEX and its eight impurities (100 +/- 2% and RSD <= 2.0% for DEX; 100 +/- 5% and RSD <= 2.0% for impurities). In addition, Strata and Strata X cartridges were identified as an alternative cartridge for the elixir and oral solution, respectively. Furthermore, the extraction efficiency of the SPE protocol was evaluated by comparing the sample preparations with and without SPE using a regular-dose product (DEX Intensol oral solution 1 mg/mL). The SPE-based HPLC method was validated as an effective procedure for the determination of DEX and impurities in DEX elixir and oral solution. The case study demonstrated that incorporation of SPE into USP monographs could significantly strengthen compendial procedures for quality control. (C) 2019 Elsevier B.V. All rights reserved. |
| 英文关键词 | Low-dose drug product Solid-phase extraction (SPE) Dexamethasone Dexamethasone elixir Dexamethasone oral solution |
| 类型 | Article |
| 语种 | 英语 |
| 国家 | USA |
| 收录类别 | SCI-E |
| WOS记录号 | WOS:000485206900020 |
| WOS关键词 | ORGANIC-COMPOUNDS |
| WOS类目 | Chemistry, Analytical ; Pharmacology & Pharmacy |
| WOS研究方向 | Chemistry ; Pharmacology & Pharmacy |
| EI主题词 | 2019-10-25 |
| 资源类型 | 期刊论文 |
| 条目标识符 | http://119.78.100.177/qdio/handle/2XILL650/310354 |
| 作者单位 | USP, Compendial Dev Lab, 12601 Twinbrook Pkwy, Rockville, MD 20852 USA |
| 推荐引用方式 GB/T 7714 | Xu, Qun. Incorporating solid-phase extraction into compendial procedures for the determination of dexamethasone and impurities in low-dose drug products[J],2019,175. |
| APA | Xu, Qun.(2019).Incorporating solid-phase extraction into compendial procedures for the determination of dexamethasone and impurities in low-dose drug products.JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS,175. |
| MLA | Xu, Qun."Incorporating solid-phase extraction into compendial procedures for the determination of dexamethasone and impurities in low-dose drug products".JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS 175(2019). |
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