Analytical quality by design aided stability indicating a robust ultra‐performance liquid chromatographic technique for the quantification of sonidegib and its organic impurities in bulk drug substance

SEPARATION SCIENCE PLUS Pub Date : 2024-01-11 DOI:10.1002/sscp.202300181

Kasturi Rajashekhar, Challa Gangu Naidu, Chebolu Naga Sesha Sai Pavan Kumar, Bondigalla Ramachandra, Raju Padiya

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Abstract

A simple quality by design aided stability indicating method was developed for quantification of sonidegib (SONI) and its process related impurities using on ultra‐performance liquid chromatography in bulk drug substance. AutoChrom and Design‐Expert software were used to predict physicochemical properties, draw Ionization graphs, and generate analytical target profile. SONI was subjected to forced degradation conditions, such as oxidative, acid hydrolysis, base hydrolysis, hydrolytic, thermal, and photolytic hydrolysis. All degradation products and process contaminants were separated using an Acquity Ethylene Bridged Hybrid C18 column in gradient elution mode with a mobile phase containing 0.02 M ammonium acetate buffer and acetonitrile: methanol (80:20 v/v). The predicted physicochemical properties are accurate and they facilitated for selection of robust conditions in development of chromatographic method with minimal trials. The developed method can be used for quantification of drug and its process related impurities in bulk drugs.

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以设计辅助分析质量稳定性，显示用于定量散装药物中索尼地布及其有机杂质的稳健超高效液相色谱技术

利用超高效液相色谱法，开发了一种简单的质量设计辅助稳定性指示方法，用于定量检测散装药物中的索尼吉布（SONI）及其工艺相关杂质。使用 AutoChrom 和 Design-Expert 软件预测理化性质、绘制电离图并生成分析目标曲线。对 SONI 进行了强制降解，如氧化、酸水解、碱水解、水解、热水解和光解。使用 Acquity 乙烯桥接混合型 C18 色谱柱，以 0.02 M 乙酸铵缓冲液和乙腈：甲醇（80:20 v/v）为流动相，在梯度洗脱模式下分离所有降解产物和工艺污染物。所预测的理化性质非常准确，有助于在开发色谱方法时以最少的试验选择可靠的条件。所开发的方法可用于定量检测散装药物中的药物及其工艺相关杂质。

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SEPARATION SCIENCE PLUS

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