相关实验视频

Updated: May 6, 2026

An In Vitro Dissolution Determination of Multi-Index Components in Tibetan Medicine Rhodiola Granules

An In Vitro Dissolution Determination of Multi-Index Components in Tibetan Medicine Rhodiola Granules

Published on: November 4, 2022

绿色稳定性指示RP-HPTLC方法用于确定商用片剂剂形式中的suvorexant

Prawez Alam¹, Faiyaz Shakeel², Mohammed H Alqarni¹

¹Department of Pharmacognosy, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-Kharj, 11942, Saudi Arabia.

|February 28, 2025

概括

开发了一种新的绿色高性能薄层染色学 (HPTLC) 方法来测量一种镇静剂药物suvorexant (SUV). 这种环保技术准确地量化平板电脑中的SUV,并评估其稳定性.

科学领域:

分析化学分析化学
法医化学法医化学
绿色化学绿色化学

背景情况:

苏沃雷克桑 (Suvorexant,简称SUV) 是一种用于治疗失眠的新型镇静/催眠药.
它的镇静和抑郁作用使其从法医角度来看具有重要意义.
现有的分析方法缺乏绿色高性能薄层染色学 (HPTLC) 方法来量化SUV.

研究的目的:

开发和验证一个逆相HPTLC方法用于suvorexant测量 (SUV).
评估开发的分析方法的绿色和稳定性指示性.
为了量化SUV在商业上可用的药片剂量形式.

主要方法:

开发用于SUV分析的逆相HPTLC方法.
在波长为255nm时检测到SUV.
使用分析生态尺度 (AES),ChlorTox和AGREE工具评估方法的绿色性.
评估方法的稳定性,准确性,精度,线性和灵敏度.
在销售的平板电脑配方中分析SUV.

主要成果:

开发的HPTLC方法表现出极好的线性 (10-1200 ng/频段),准确性 (98.18-99.30%回收),精度 (0.78-0.94%CV) 和灵敏度 (LOD=3.32,LOQ=9.98 ng/频段).
该方法获得了高的绿色分数:AES=93,总ChlorTox=0.96g,以及AGREE=0.88.
该方法被证明是稳定性指示,在其降解产品的存在下准确量化SUV.
在市场上销售的平板电脑样本中,标签上的SUV数量的含量分别为98.18%和101.32%.

结论:

已经建立了一种新的,经过验证的,环保的HPTLC方法,用于在药片中量化剂 (SUV).
该方法是稳固的,准确的,灵敏的,并且具有特殊的绿色特征.
这种绿色HPTLC方法适用于药物配方和法医分析中SUV的常规监测.

关键词:

法医医学法医学的医学.绿色的评价绿色的评价这是RP-HPTLC.这是一种超级复杂剂 (suvorexant).验证验证验证验证

更多相关视频

HPLC Coupled with Chemical Fingerprinting for Multi-Pattern Recognition for Identifying the Authenticity of Clematidis Armandii Caulis

HPLC Coupled with Chemical Fingerprinting for Multi-Pattern Recognition for Identifying the Authenticity of Clematidis Armandii Caulis

Published on: November 11, 2022

Formation of Dispersible Taohong Siwu Tablets

Formation of Dispersible Taohong Siwu Tablets

Published on: February 3, 2023

相关概念视频

In Vitro Drug Dissolution: Compendial Testing Models II

In Vitro Drug Dissolution: Compendial Testing Models II

Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients,...

In Vitro Drug Dissolution: Alternative Methods

In Vitro Drug Dissolution: Alternative Methods

Alternative drug dissolution methods include the rotating bottle, intrinsic dissolution test, peristalsis, and the Franz diffusion cell method. The rotating bottle method involves meticulously rotating tightly capped controlled-release beads in a temperature-controlled bath. Periodic decanting of samples allows for residue assay, followed by refilling with fresh medium and testing at various pH levels to emulate the gastrointestinal tract conditions.In contrast, the intrinsic dissolution test...

Drug Dissolution: Requirements and Profile Comparison

The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...

Clinically Relevant Drug Product Specifications: Methods of Establishment

Clinically Relevant Drug Product Specifications: Methods of Establishment

Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...

Drug Product Stability

Drug Product Stability

The long-term stability of drug products is critical to ensuring their quality, safety, and effectiveness over time. Stability directly influences a product's ability to maintain its intended characteristics, ensuring it performs as expected during its intended shelf life. Key attributes such as drug potency, impurities, dissolution, and other physicochemical measures of performance are tested to assess stability. These parameters indicate how well the product retains its quality over time and...

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...