Department of Quality Assurance, Maliba Pharmacy College, Uka Tarsadia University, Maliba Campus, Bardoli-Mahuva Road, Tarsadi, Dist Surat, Barodli 394350, India.
Department of Quality Assurance, L. M. College of Pharmacy, Navrangpura, Opp. Gujarat University, Ahmedabad 380009, India.
J Chromatogr Sci. 2022 Feb 16;60(2):179-185. doi: 10.1093/chromsci/bmab014.
Pranlukast hydrate is an anti-asthmatic drug and used in the treatment of acute asthma. Stability-indicating RP-HPLC method for pranlukast hydrate has been developed and validated. The reverse phase high performance liquid chromatographic method was developed using Shimadzu Column: Kromosil 100 C18 (150 mm × 4.6 mm × 5 μm) and mobile phase Acetonitrile: 0.1% Glacial acetic acid (85: 15% v/v). Eluent was monitored with UV-detector at 262 nm with a flow rate of 0.5 mL/min, temperature maintained at 30°C. Stress testing was carried out in acidic, alkaline, oxidative, photolytic and dry heat degradation conditions. The method was validated as per the International Conference for Harmonization guidelines and includes specificity, accuracy, precision, linearity and limit of quantitation and detection parameters. A relative standard deviation <2% indicates the developed method was precise. The accuracy of the method was represented by recovery studies ranging between 99.41 and 99.72%. In acid, alkaline, oxidative stress conditions, pranlukast hydrate degrades significantly and in photolytic, dry heat, hydrolytic conditions remain stable. This proposed method is suitable for the analysis of pranlukast hydrate in its laboratory mixture.
普拉鲁司特水合物是一种抗哮喘药物，用于治疗急性哮喘。已经开发并验证了用于普拉鲁司特水合物的稳定指示性反相高效液相色谱法。该反相高效液相色谱法是使用岛津柱：Kromosil 100 C18（150mm×4.6mm×5μm）和流动相乙腈：0.1%冰醋酸（85：15%v/v）开发的。洗脱液在 262nm 处用紫外检测器监测，流速为 0.5mL/min，温度保持在 30°C。在酸性、碱性、氧化、光解和干热降解条件下进行了应激试验。该方法按照国际协调会议指南进行了验证，包括专属性、准确性、精密度、线性和定量限以及检测参数。相对标准偏差<2%表明所开发的方法是精确的。方法的准确性通过回收率研究来表示，回收率在 99.41%至 99.72%之间。在酸性、碱性、氧化应激条件下，普拉鲁司特水合物明显降解，而在光解、干热、水解条件下保持稳定。该方法适用于普拉鲁司特水合物在实验室混合物中的分析。
