开发和验证一种强大的RP-HPLC方法,用于在自我微乳化药物输送系统中量化达沙替尼
Nitin V Kokare1, Rohit R Shah2, Rana Salman Saad Al-Rashidi3
1Department of Quality Assurance, Appasaheb Birnale College of Pharmacy, Sangli, 416416, Maharashtra, India.
International journal of analytical chemistry
|February 4, 2026
概括
一种新的反相高性能液态色谱 (RP-HPLC) 方法准确地量化了自微乳化药物输送系统 (SMEDDS) 中的达沙替尼. 这种经过验证的方法提高了达沙替尼的生物可用性,用于治疗慢性髓性白血病.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
背景情况:
- 达沙替尼是一种慢性髓性白血病 (CML) 治疗方法,其口服生物可用性较差.
- 研究自微乳化药物递送系统 (SMEDDS) 的目的是提高达沙替尼的溶解和生物可用性.
研究的目的:
- 开发和验证一种新的反相高性能液态染色学 (RP-HPLC) 方法,用于对达沙替尼的定量分析.
- 评估开发的RP-HPLC方法是否适合在SMEDDS配方内定量达沙替尼.
主要方法:
- 建立了一个RP-HPLC方法,使用甲醇和0.1%的三酸移动相 (55:45,v/v),在324nm检测.
- 在SMEDDS配方 (Capryol 90,Transcutol HP,Tween 40) 中进行了达沙替尼的量化.
- 方法验证是根据国际协调理事会 (ICH) 的指导方针进行的.
主要成果:
- 该RP-HPLC方法表现出极好的线性 (R2 = 0.9993),准确性 (98-101%的回收率) 和精度 (RSD = 0.73%).
- 该方法表现出强大的稳定性和可靠性,检测极限低 (0.17μg/mL) 和量化极限低 (0.50μg/mL).
结论:
- 开发的RP-HPLC方法得到了验证,并且适合在SMEDDS配方中量化达沙替尼.
- 这种强大且具有成本效益的分析工具支持开发和质量控制含达沙替尼的SMEDDS.
相关概念视频
In Vitro Drug Release Testing: Overview, Development and Validation
347
In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
347
Drug Delivery: Overview
863
The selection of a drug's delivery route depends upon its physicochemical properties, including lipid or water solubility and ionization, as well as the therapeutic requirement, such as immediate or sustained effect. These routes can be divided into three primary categories: enteral, parenteral, and topical.
Enteral delivery involves administering drugs directly through swallowing, sublingual placement, or buccal application. Orally administered drugs predominantly navigate the...
Enteral delivery involves administering drugs directly through swallowing, sublingual placement, or buccal application. Orally administered drugs predominantly navigate the...
863
Drug Delivery: Enteral Route
1.8K
The enteral drug administration involves three primary routes: oral, sublingual, and buccal. Oral ingestion is the most prevalent, safe, economical, and convenient method for drug administration. However, it has certain drawbacks, including limited absorption due to the drug's low water solubility or poor membrane permeability, possible emesis from GI mucosa irritation, destruction of drugs by digestive enzymes or low gastric pH, and irregular absorption along with food or other drugs.
1.8K
Drug Delivery: Parenteral Route
1.7K
The parenteral route is a critical method of drug administration. It delivers compounds directly into the systemic circulation and bypasses the gastrointestinal tract. This approach is particularly advantageous for drugs that exhibit poor absorption or instability when administered orally.
There are three primary parenteral routes: intravenous (IV), intramuscular (IM), and subcutaneous (SC). The IV route introduces the drug directly into the bloodstream, ensuring immediate action. The IM route...
There are three primary parenteral routes: intravenous (IV), intramuscular (IM), and subcutaneous (SC). The IV route introduces the drug directly into the bloodstream, ensuring immediate action. The IM route...
1.7K
Reliability and Validity
13.9K
Reliability and validity are two important considerations that must be made with any type of data collection. Reliability refers to the ability to consistently produce a given result. In the context of psychological research, this would mean that any instruments or tools used to collect data do so in consistent, reproducible ways.
13.9K
Drug Delivery: Miscellaneous Routes
832
Drug delivery methods like oral inhalation, nasal sprays, transdermal patches, eye drops, intravitreal injection, and rectal administration provide localized effects with reduced toxicity.
Oral inhalation and nasal sprays swiftly transfer drugs across the respiratory epithelium's mucosal layer. Inhaled glucocorticoids and bronchodilators directly target lung conditions such as asthma, while fluticasone nasal spray mitigates allergic rhinitis.
Transdermal patches transport drugs...
Oral inhalation and nasal sprays swiftly transfer drugs across the respiratory epithelium's mucosal layer. Inhaled glucocorticoids and bronchodilators directly target lung conditions such as asthma, while fluticasone nasal spray mitigates allergic rhinitis.
Transdermal patches transport drugs...
832


