用于同时测定多柔比星和克霉唑的反相高效液相色谱法的开发与验证

IF 1.6 4区医学 Q4 BIOCHEMICAL RESEARCH METHODS

Assay and drug development technologies Pub Date : 2024-02-01 Epub Date: 2023-12-27 DOI:10.1089/adt.2023.057

Priyanka Sharma, Bhupinder Kapoor, Md Sadique Hussain, Gurvinder Singh, Pooja Rani, Balraj Saini, Pankaj Wadhwa, Rajesh Kumar

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引用次数: 0

摘要

建立了同时测定多柔比星和克霉唑的反相高效液相色谱分析方法。采用 Nucleodur C18 色谱柱（250×4.6 mm，5 μm），梯度洗脱。流动相为 0.2%甲酸（pH 3.2）和乙腈。采用光电二极管阵列检测器在 276 nm 波长（两种药物的等基点）上对两种药物（多柔比星和克霉唑）进行检测和定量。该方法的特异性、线性、准确性、精密度和稳健性均符合现行的国际人用药品技术要求协调理事会（International Council for Harmonization of Technical Requirements of Pharmaceuticals for Human Use）准则。所开发的方法呈线性响应（R2 > 0.999），准确（回收率为 97%-103%）、精确（分辨率≤1.0%）、灵敏、特异。因此，所开发的 RP-HPLC 方法成功地验证了这两种药物的同时估算，可用于正在开发的制剂中这两种药物的估算。

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Development and Validation of Reverse-Phase High-Performance Liquid Chromatography Method for Simultaneous Estimation of Doxorubicin and Clotrimazole.

A reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed to analyze the simultaneous estimation of doxorubicin and clotrimazole. The method was achieved by Nucleodur C18 column with dimension 250 × 4.6 mm (5 μm) using gradient elution. The mobile phase contained 0.2% formic acid (pH 3.2) and acetonitrile. The flow rate was kept at 1.0 mL/min and detection and quantitation of both drugs (doxorubicin and clotrimazole) were achieved using a photodiode array detector at 276 nm, which was the isosbestic point for both drugs. The proposed method was validated according to the current International Council for Harmonization of Technical Requirements of Pharmaceuticals for Human Use guidelines for specificity, linearity, accuracy, precision, and robustness. The developed method showed a linear response (R² > 0.999), and was accurate (recoveries 97%-103%), precise (resolution ≤1.0%), sensitive, and specific. Thus, the developed RP-HPLC method for the simultaneous estimation of both drugs was successfully validated and can be utilized for the estimation of these drugs in the formulations being developed.

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来源期刊

Assay and drug development technologies 医学-生化研究方法

CiteScore

3.60

自引率

0.00%

发文量

审稿时长

>12 weeks

期刊介绍： ASSAY and Drug Development Technologies provides access to novel techniques and robust tools that enable critical advances in early-stage screening. This research published in the Journal leads to important therapeutics and platforms for drug discovery and development. This reputable peer-reviewed journal features original papers application-oriented technology reviews, topical issues on novel and burgeoning areas of research, and reports in methodology and technology application. ASSAY and Drug Development Technologies coverage includes: -Assay design, target development, and high-throughput technologies- Hit to Lead optimization and medicinal chemistry through preclinical candidate selection- Lab automation, sample management, bioinformatics, data mining, virtual screening, and data analysis- Approaches to assays configured for gene families, inherited, and infectious diseases- Assays and strategies for adapting model organisms to drug discovery- The use of stem cells as models of disease- Translation of phenotypic outputs to target identification- Exploration and mechanistic studies of the technical basis for assay and screening artifacts