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Risk Assessment-Based Enhanced Analytical Quality-by-Design Approach to Eco-Friendly and Economical Multicomponent Spectrophotometric Methods for Simultaneous Estimation of Montelukast Sodium and Bilastine
Journal of AOAC INTERNATIONAL ( IF 1.6 ) Pub Date : 2021-07-03 , DOI: 10.1093/jaoacint/qsab089
Pintu Prajapati 1 , Jayesh Tamboli 1 , Parth Surati 1 , Ashish Mishra 1
Affiliation  

Background Concomitant montelukast and bilastine are used as additive therapy for seasonal allergic rhinoconjuctivitis and mild to moderate asthma. According to a literature review, no UV-visible spectrophotometric method has been reported yet for simultaneous estimation of montelukast sodium and bilastine in their combined pharmaceutical dosage forms. Objective Five different multicomponent spectrophotometric methods were therefore developed and validated for simultaneous estimation of montelukast sodium and bilastine using a risk assessment-based enhanced analytical quality-by-design approach. Method The identification and assessment of method risk parameters were carried out using the risk priority number ranking and filtering method according to the International Conference on Harmonization (ICH) Q9 guideline. The wavelength for detection and solvents such as 0.1 N NaOH and 0.1 N HCl were found to be critical method parameters for the development of the target methods. The developed methods were validated as per the ICH Q2(R1) guideline. Results The developed and validated methods were applied for assay of combined pharmaceutical dosage forms of montelukast sodium and bilastine and results were found to be in good agreement with their label claims. Conclusions The developed methods did not include the usage of any organic solvent and are a good alternative to the costly chromatography method. Hence, the methods are eco-friendly and economical for the simultaneous estimation of bilastine and montelukast sodium. Highlights Five multicomponent spectrophotometric methods were developed for simultaneous estimation of montelukast sodium and bilastine using a risk-based analytical quality-by-design approach. An assay of combined tablet dosage forms of montelukast sodium and bilastine was then carried out using the developed methods.

中文翻译:

基于风险评估的增强型分析质量设计方法用于同时估算孟鲁司特钠和比拉斯汀的环保和经济的多组分分光光度法

背景 伴随的孟鲁司特和比拉斯汀被用作季节性过敏性鼻结膜炎和轻度至中度哮喘的附加疗法。根据文献综述,目前还没有报道用紫外-可见分光光度法同时测定其联合药物剂型中的孟鲁司特钠和比拉斯汀。目的 因此,开发并验证了五种不同的多组分分光光度法,用于使用基于风险评估的增强分析质量设计方法同时估计孟鲁司特钠和比拉斯汀。方法 根据国际协调会议(ICH)Q9 指南,使用风险优先级数排序和过滤方法进行方法风险参数的识别和评估。检测波长和 0.1 N NaOH 和 0.1 N HCl 等溶剂被发现是开发目标方法的关键方法参数。开发的方法根据 ICH Q2(R1) 指南进行了验证。结果 开发和验证的方法用于检测孟鲁司特钠和比拉斯汀的组合药物剂型,发现结果与其标签声明非常一致。结论 开发的方法不包括任何有机溶剂的使用,是昂贵的色谱方法的良好替代品。因此,该方法对于同时测定比拉斯汀和孟鲁司特钠是环保且经济的。亮点 开发了五种多组分分光光度法,使用基于风险的分析质量设计方法同时估计孟鲁司特钠和比拉斯汀。然后使用开发的方法对孟鲁司特钠和比拉斯汀的组合片剂剂型进行了测定。
更新日期:2021-07-03
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