AQbD enabled method development and quantification of asiaticoside in foam-based formulations

IF 0.8 4区工程技术 Q4 CHEMISTRY, ANALYTICAL Accreditation and Quality Assurance Pub Date : 2024-06-24 DOI:10.1007/s00769-024-01608-8

Mohit Kumar, Anjali Pant, Shruti Chopra, Amit Bhatia

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Abstract

The purpose of this study was to develop a rapid, sensitive, and precise RP-HPLC (Reverse-Phase High-Performance Liquid Chromatography) method for the estimation of asiaticoside (AC) using the analytical quality by design (AQbD) approach. Initially, important AQbD prerequisites like analytical target profile (ATP) and critical analytical attributes (CAAs), such as theoretical plates and tailing factor, were defined. The final chromatographic conditions for the analysis of AC consist of stationary phase {A COSMOSIL 5C18-MS-II packed column (250 mm × 4.6 mm i.d, 5 µm)}, mobile phase was S_mix {Methanol and Acetonitrile (40:25)}, and Orthophosphoric acid buffer (0.025 % OPA) in the ratio of 65:35 v/v at a flow rate of 1.0 mL/min and detection wavelength was 205 nm. The diversity in CAAs with different inputs was explained using the Ishikawa fishbone diagram. Taguchi design was selected as the first screening design to choose the critical material attributes (CMAs) that influence the method development. Subsequently, for more systematic optimization of the chromatographic technique and evaluation of CAAs, central composite design (CCD) was employed. In conclusion, the findings of the present study validated the utility of AQbD in the systemic design of a liquid chromatographic method with fine sensitivity for AC estimation in pharmaceutical products.

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AQbD使泡沫配方中积雪草苷的方法开发和定量成为可能

本研究的目的是建立一种快速、灵敏、精确的反相高效液相色谱（RP-HPLC）方法，利用设计质量法（AQbD）测定积雪草苷（AC）的含量。首先，定义了重要的AQbD先决条件，如分析目标剖面（ATP）和关键分析属性（CAAs），如理论板和尾尾因子。AC分析的最终色谱条件为：固定相{A COSMOSIL 5C18-MS-II填充柱（250 mm × 4.6 mm, 5µm）}，流动相为Smix{甲醇和乙腈（40:25）}，正磷酸缓冲液（0.025% OPA），比例为65:35 v/v，流速为1.0 mL/min，检测波长为205 nm。利用Ishikawa鱼骨图解释了不同投入条件下CAAs的多样性。选择田口设计作为第一个筛选设计，选择影响方法发展的关键材料属性（cma）。随后，为了更系统地优化色谱技术和评价CAAs，采用中心复合设计（CCD）。总之，本研究的结果验证了AQbD在系统设计一种具有良好灵敏度的药物中AC估计的液相色谱方法中的实用性。

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来源期刊

Accreditation and Quality Assurance 工程技术-分析化学

CiteScore

1.80

自引率

22.20%

发文量

审稿时长

6-12 weeks

期刊介绍： Accreditation and Quality Assurance has established itself as the leading information and discussion forum for all aspects relevant to quality, transparency and reliability of measurement results in chemical and biological sciences. The journal serves the information needs of researchers, practitioners and decision makers dealing with quality assurance and quality management, including the development and application of metrological principles and concepts such as traceability or measurement uncertainty in the following fields: environment, nutrition, consumer protection, geology, metallurgy, pharmacy, forensics, clinical chemistry and laboratory medicine, and microbiology.