Prajapati Pintu, Dixit Varsha, Pulusu Veera Shakar, Chauhan Renu, Shah Shailesh
Department of Quality Assurance, Maliba Pharmacy College, Surat, Gujarat, India.
Department of Chemistry and Biochemistry, Ohio University, Anthens, Ohio, USA.
J Sep Sci. 2023 Oct;46(19):e2300332. doi: 10.1002/jssc.202300332. Epub 2023 Jul 21.
Cilnidipine is a calcium channel blocker that is used to treat cardiac diseases such as angina and high blood pressure. Several column and planar chromatographic methods for estimating cilnidipine in pharmaceutical dosage forms have been documented. However, these method developments have been carried out employing organic solvents such as acetonitrile, methanol, toluene, chloroform, and others as mobile phase components or as sample pretreatment diluents. These organic solvents are neurotoxic and teratogenic to humans and aquatic animals, according to International Council for Harmonization Q3C (R8) recommendations. According to the green analytical chemistry approach, such organic solvents should be reduced or removed during the development of chromatographic methods for environmental protection and the safety of human and aquatic animal life. As a result, the stability-indicating chromatographic estimation of cilnidipine was performed utilizing less toxic organic solvents. To prevent organic solvent waste during method development, mobile-phase optimization was performed using the design of experiment-based response surface modeling. Cilnidipine has been subjected to hydrolysis, oxidation, photolysis, and dry-heat decomposition to determine its stability. The greenness profiles of the suggested and published chromatographic methods were examined using the national environment method index, analytical greenness calculator, green analytical procedure index software, and eco-scale assessment tool.
西尼地平是一种钙通道阻滞剂，用于治疗心绞痛和高血压等心脏病。已经记录了几种用于估算药物剂型中西尼地平的柱色谱法和平面色谱法。然而，这些方法的开发是使用乙腈、甲醇、甲苯、氯仿等有机溶剂作为流动相成分或作为样品预处理稀释剂进行的。根据国际协调理事会Q3C（R8）建议，这些有机溶剂对人类和水生动物具有神经毒性和致畸性。根据绿色分析化学方法，在色谱方法开发过程中应减少或去除此类有机溶剂，以保护环境以及人类和水生动物的生命安全。因此，利用毒性较小的有机溶剂对西尼地平进行了稳定性指示色谱估算。为了在方法开发过程中防止有机溶剂浪费，使用基于实验设计的响应面建模进行了流动相优化。对西尼地平进行了水解、氧化、光解和干热分解，以确定其稳定性。使用国家环境方法指数、分析绿色度计算器、绿色分析程序指数软件和生态规模评估工具对建议的和已发表的色谱方法的绿色度概况进行了检查。
