Prajapati Pintu, Shahi Abhinandan, Acharya Aneri, Shah Shailesh
Department of Quality Assurance, Maliba Pharmacy College, Maliba Campus, Bardoli-Mahuva Road, Tarsadi, Mahuva, Surat, Gujarat 394 350, India.
J AOAC Int. 2022 Dec 22;106(1):250-260. doi: 10.1093/jaoacint/qsac086.
Azilsartan medoxomil (AZL) is an anti-hypertensive drug, and its numerous FDCs are used for the treatment of hypertension. Numerous chromatographic methods have been reported for the estimation of FDCs of AZL, but analysts have to establish a separate chromatographic condition for the analysis of each FDC of AZL. No reverse-phase high-pressure liquid chromatography (RP-HPLC) method has been reported yet that can be used for synchronous estimation of multiple FDCs of AZL.
Hence, the RP-HPLC-PDA method has been developed for synchronous estimation of multiple FDCs of AZL to save time, cost, and solvent for the analysis.
The RP-HPLC-PDA method has been developed by the implementation of the analytical quality by design (AQbD) approach based on chemometric and DoE as per the upcoming International Council for Harmonization (ICH) Q14 guideline.
The method was applied for synchronous estimation of multiple FDCs of AZL, and the assay results were found in compliance with the labeled claim of the FDCs.
The developed method requires less time, cost, and organic solvent for analysis of the said pharmaceutical dosage forms compared to published chromatographic methods. Hence, the developed method is green and multipurpose for the estimation of multiple FDCs of AZL.
Development and validation of RP-HPLC method for synchronous estimation of multiple FDCs of AZL using chemometric (principal component analysis and PLS) and design of experiments (DoE). Applications of the method for synchronous estimation of multiple FDCs of AZL.
阿齐沙坦美洛昔酯（AZL）是一种抗高血压药物，其众多固定剂量复方制剂（FDC）用于治疗高血压。已有多种色谱方法用于测定AZL的FDC，但分析人员必须为AZL的每种FDC分析建立单独的色谱条件。目前尚未报道可用于同步测定AZL多种FDC的反相高效液相色谱（RP-HPLC）方法。
因此，开发了RP-HPLC-二极管阵列检测（PDA）法，用于同步测定AZL的多种FDC，以节省分析时间、成本和溶剂。
根据即将出台的国际协调理事会（ICH）Q14指南，通过基于化学计量学和实验设计（DoE）的质量源于设计（AQbD）方法开发了RP-HPLC-PDA法。
该方法用于同步测定AZL的多种FDC，测定结果符合FDC的标示要求。
与已发表的色谱方法相比，所开发的方法在分析上述药物剂型时所需时间、成本和有机溶剂更少。因此，所开发的方法对于测定AZL的多种FDC是绿色且多功能的。
使用化学计量学（主成分分析和偏最小二乘法）和实验设计（DoE）开发并验证RP-HPLC法用于同步测定AZL的多种FDC。该方法在同步测定AZL多种FDC中的应用。
