Prajapati Pintu, Tailor Pratik, 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 Chromatogr Sci. 2023 Oct 3;61(8):725-736. doi: 10.1093/chromsci/bmac045.
Hypertension is the most prominent disease found in people due to stressful routines and the working environment. The fixed-dose combination (FDC) of azilsartan medoxomil (AZL) and cilnidipine (CLN) is used for the treatment of hypertension. According to the green chemistry approach, organic solvents should be minimized in the development of the analytical method for the safety of the environment. The high-performance thin-layer chromatographic (HPTLC) method required less amount of organic solvent for the analysis of the drug. Hence, it was thought of interest to develop an accurate and robust HPTLC method for the estimation of AZL and CLN in their FDC. The development of the method was carried out by the implementation of the analytical quality by design approach using the Taguchi orthogonal array and BBD for regulatory compliance as per the upcoming ICH Q14 guideline. The analytical design space and control strategy was framed for the lifecycle management of the method. The chromatographic separation was performed using silica gel GF254 and toluene ethylacetate-methanol (6.5 + 1.5 + 2.0, v/v). The method was applied for the assay of FDC and results were found in compliance with the labeled claim. The developed method was also applied for the estimation of spiked human plasma and the recovered amount of drugs was found in the range of 80-85%.
高血压是人们因紧张的日常工作和工作环境而患上的最常见疾病。阿齐沙坦美洛昔酯（AZL）和西尼地平（CLN）的固定剂量复方制剂（FDC）用于治疗高血压。根据绿色化学方法，在开发分析方法时应尽量减少有机溶剂的使用，以保护环境安全。高效薄层色谱（HPTLC）法在分析该药物时所需有机溶剂较少。因此，人们认为开发一种准确且稳健的HPTLC法来测定其FDC中的AZL和CLN很有意义。该方法的开发是通过采用田口正交阵列和BBD按照即将出台的ICH Q14指南实施设计质量分析方法来进行的。为该方法的生命周期管理构建了分析设计空间和控制策略。使用硅胶GF254和甲苯 - 乙酸乙酯 - 甲醇（6.5 + 1.5 + 2.0，v/v）进行色谱分离。该方法用于FDC的含量测定，结果符合标签声明。所开发的方法还用于加标人血浆的测定，药物回收率在80 - 85%范围内。
