采用白分析化学和分析质量设计的混合原理同时测定维格列汀和达格列净。
Simultaneous Chromatographic Estimation of Vildagliptin and Dapagliflozin Using Hybrid Principles of White Analytical Chemistry and Analytical Quality by Design.
机构信息
Maliba Pharmacy College, Department of Quality Assurance, Maliba Campus, Bardoli-Mahuva Road, Tarsadi, Mahuva, Surat, Gujarat 394 350, India.
Ohio University, Department of Chemistry and Biochemistry, Athens, OH 45701, USA.
出版信息
J AOAC Int. 2024 Jan 4;107(1):212-222. doi: 10.1093/jaoacint/qsad108.
BACKGROUND
The fixed-dose combination of vildagliptin (VDG) and dapagliflozin (DGZ) is used in the treatment of type 2 diabetes mellitus. According to the literature survey, RP-HPLC and HPTLC methods have been reported for routine analysis of VDG and DGZ. These chromatographic methods have been developed using potentially neurotoxic and teratogenic solvents, which are unsafe for human and aquatic animal life and hazardous to the environment. These types of organic solvents shall be replaced or reduced during chromatographic analysis of drugs for the safety of human and aquatic animal life and the protection of the environment. The novel white analytical chemistry (WAC) approach has been introduced, which emphasizes robust, green, user-friendly, economical, and rapid analysis of drug samples.
OBJECTIVE
Hence, the WAC-based RP-HPLC method has been developed for the estimation of VDG and DGZ using lower toxic and economical solvents.
METHOD
The development of the RP-HPLC method includes the implementation of the analytical quality by design approach using principles of design of experiments to reduce organic waste generation and regulatory compliance of analytical method. The central composite design was applied for response surface modeling (RSM) and optimization of the RP-HPLC method. The method validation was carried out according to ICH Q2 (R1) guidelines.
RESULTS
The fixed-dose combinations of VDG and DGZ were assayed, and results were found in compliance with their labeled claim. The published and proposed RP-HPLC methods were assessed for chromatographic analysis of VDG and DGZ using the Red-Green-Blue (RGB) model, AGREE calculator, Eco-Scale Assessment tool, GAPI software, and NEMI standards.
CONCLUSIONS
The proposed method was found to be robust, green, economical, and user-friendly for chromatographic analysis of VDG and DGZ. The proposed method can be an economical and eco-friendly analytical tool in the pharmaceutical industry for quality control and routine analysis of fixed-dose combinations of VDG and DGZ.
HIGHLIGHTS
Hybrid principles of WAC and analytical quality by design to RP-HPLC method for simultaneous estimation of VDG and DGZ in their fixed-dose combinations.
背景
维格列汀（VDG）和达格列净（DGZ）的固定剂量组合用于治疗 2 型糖尿病。根据文献调查，已经报道了用于常规分析 VDG 和 DGZ 的 RP-HPLC 和 HPTLC 方法。这些色谱方法是使用潜在的神经毒性和致畸性溶剂开发的，这些溶剂对人类和水生动物的生命不安全，对环境也有危害。在药物的色谱分析中，应取代或减少这些类型的有机溶剂，以保障人类和水生动物的生命安全，保护环境。已经引入了新型的白色分析化学（WAC）方法，该方法强调了对药物样品进行稳健、绿色、用户友好、经济和快速的分析。
目的
因此，开发了基于 WAC 的 RP-HPLC 方法，以使用毒性较低且经济的溶剂来估算 VDG 和 DGZ。
方法
RP-HPLC 方法的开发包括使用实验设计原理实施分析质量设计方法，以减少有机废物的产生并符合分析方法的监管要求。中心复合设计用于响应面建模（RSM）和 RP-HPLC 方法的优化。根据 ICH Q2（R1）指南进行方法验证。
结果
对 VDG 和 DGZ 的固定剂量组合进行了测定，结果符合其标签声称。使用 Red-Green-Blue（RGB）模型、AGREE 计算器、Eco-Scale 评估工具、GAPI 软件和 NEMI 标准，对已发表和提出的 RP-HPLC 方法进行了评估，以用于 VDG 和 DGZ 的色谱分析。
结论
该方法被发现对于 VDG 和 DGZ 的色谱分析具有稳健性、绿色性、经济性和用户友好性。对于 VDG 和 DGZ 的固定剂量组合的质量控制和常规分析，该方法可以成为制药行业中经济且环保的分析工具。
亮点
WAC 和分析质量设计的混合原理用于 RP-HPLC 方法，用于同时估算其固定剂量组合中的 VDG 和 DGZ。
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