Abstract

Failure mode critical effect analysis and design of experiment-based high performance thin layer chromatography (HPTLC) method has been developed for simultaneous estimation of lornoxicam (LOC) and eperisone hydrochloride (EPR). Failure modes were identified on the basis of prior knowledge and experimental data with the help of Ishikawa diagram for the development of method. The criticality of failure mode was assessed by giving risk priority number and criticality rank on the basis of preliminary experimental trials. The identified critical failure modes were analyzed for their effect by design of experiment (DoE)-based Plackett–Burman screening design. From 11 critical factors, the volume of methanol and modifier in mobile phase composition were found as critical failure modes. Critical failure mode was further analyzed by DoE based on central composite design for study of their relationship with resolution of both drugs. Quadratic model suggested by design was further used for failure mode risk control and navigation of design space for a resolution of both drugs more than 1.5. Failure mode risk control strategy was set for robust HPTLC method for simultaneous estimation of both drugs in laboratory mixture. Developed and validated HPTLC method was applied for assay of LOC and EPR in their laboratory mixture and assay values were found in good agreement with a spiked amount of drugs.

中文翻译：

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同时估计氯诺昔康和盐酸乙哌立松的失效模式临界效应分析和基于实验的鲁棒色谱方法设计。

摘要

已经开发了失效模式临界效应分析和基于实验的高性能薄层色谱（HPTLC）方法的设计，用于同时评估氯诺昔康（LOC）和盐酸艾培瑞松（EPR）。基于先验知识和实验数据，借助Ishikawa图确定了失效模式，以开发方法。通过在初步实验的基础上给出风险优先级数字和危险度等级，评估了失效模式的危险度。通过基于实验（DoE）的Plackett-Burman筛选设计的设计，对已识别的严重故障模式的影响进行了分析。从11个关键因素中，发现流动相成分中甲醇和改性剂的量为关键破坏模式。美国能源部基于中央复合设计进一步分析了严重衰竭模式，以研究其与两种药物的分辨率之间的关系。设计提出的二次模型进一步用于故障模式风险控制和设计空间导航，以使两种药物的分辨率均超过1.5。针对健壮的HPTLC方法设置了故障模式风险控制策略，以便同时评估实验室混合物中的两种药物。已开发和验证的HPTLC方法用于实验室混合物中LOC和EPR的测定，并且测定值与加标的药物量非常吻合。针对健壮的HPTLC方法设置了故障模式风险控制策略，以便同时评估实验室混合物中的两种药物。已开发和验证的HPTLC方法用于实验室混合物中LOC和EPR的测定，并且测定值与加标的药物量非常吻合。针对健壮的HPTLC方法设置了故障模式风险控制策略，以便同时评估实验室混合物中的两种药物。已开发和验证的HPTLC方法用于实验室混合物中LOC和EPR的测定，并且测定值与加标的药物量非常吻合。