Maliba Pharmacy College, Department of Quality Assurance, Maliba Campus, Bardoli-Mahuva Road, Tarsadi, Mahuva, Surat, Gujarat 394 350, India.
J AOAC Int. 2023 Mar 1;106(2):501-513. doi: 10.1093/jaoacint/qsac107.
According to the literature review, organic solvents such as methanol, acetonitrile, toluene, and carbon tetrachloride have been used for the chromatographic analysis of aripiprazole (APZ). The green chemistry approach recommends these organic solvents are unsafe for analysts and the environment and should be avoided or minimized in chromatographic analysis.
Hence, the stability-indicating assay method (SIAM) has been developed for the estimation of aripiprazole using safe organic solvents.
The quality risk management was started with risk identification, which was followed by risk assessment. By the risk assessment process, seven analytical risk factors (ARFs) were found to be potentially risky for method development. Further risk analysis was done by Taguchi OA design for the study of the main effect of ARF on resolution between the peaks. Design of experiments (DoE)-based response surface modeling (RSM) was performed by central composite design. Method operable design region (MODR) was navigated for resolution between peaks more than 1.0 for risk control. After navigation of the MODR, a risk review was done by validation of the design model for SIAM.
Control strategy was set for ARFs and separation was carried out on the precoated aluminum plate with silica gel 60 F254 using ethyl acetate-ethanol (8.0 + 2.0, v/v) as the mobile phase keeping 15 min saturation time. The developed method was validated as per the International Council for Harmonisation (ICH) Q2 (R1) guideline. The developed SIAM was applied for the assay of aripiprazole in its tablet, and results were found in agreement with the labeled claim.
The organic solvents ethyl acetate and ethanol used in chromatographic analysis of APZ are recommended as safe organic solvents by the ICH Q3C guidelines. The method greenness profiles of developed and published methods were evaluated by national environmental method index (NEMI) and analytical greenness (AGREE) methods. The developed method was found to be safe and green for chromatographic analysis of APZ.
Development of a green, robust, accurate, and precise stability-indicating HPTLC method for estimation of APZ. The quality risk management (QRM) and DoE-based analytical quality by design (AQbD) approach was implemented in support of the green analytical chemistry concept. Estimation of greenness profile of method by NEMI and AGREE methods.
根据文献综述，甲醇、乙腈、甲苯和四氯化碳等有机溶剂已用于阿立哌唑（APZ）的色谱分析。绿色化学方法建议这些有机溶剂对分析人员和环境不安全，应在色谱分析中避免或最小化使用。
因此，开发了一种使用安全有机溶剂的阿立哌唑含量测定的稳定性指示分析方法（SIAM）。
质量风险管理从风险识别开始，然后进行风险评估。通过风险评估过程，发现七个分析风险因素（ARFs）对方法开发具有潜在风险。通过田口正交设计（OA）进一步对主效应进行风险分析，研究 ARF 对峰分离度的影响。采用中心复合设计（CCD）进行基于实验设计（DoE）的响应面建模（RSM）。为了控制风险，通过峰分离度大于 1.0 来导航方法可操作设计区域（MODR）。在 MODR 导航之后，通过验证设计模型来进行 SIAM 的风险审查。
设定了 ARF 的控制策略，并使用硅胶 60 F254 预制板，以乙酸乙酯-乙醇（8.0+2.0，v/v）作为流动相，保持 15 分钟的饱和时间进行分离。所开发的方法符合国际人用药品注册技术协调会（ICH）Q2（R1）指南的要求。该 SIAM 用于其片剂的含量测定，结果与标签声称相符。
ICH Q3C 指南推荐在 APZ 的色谱分析中使用乙酸乙酯和乙醇作为安全有机溶剂。采用国家环境方法指数（NEMI）和分析绿色度（AGREE）方法评估所开发和已发表方法的方法绿色度概况。所开发的方法被认为是安全和绿色的，可用于 APZ 的色谱分析。
开发了一种用于阿立哌唑测定的绿色、稳健、准确和精密的高效薄层色谱法。实施了质量风险管理（QRM）和基于实验设计的分析质量保证（AQbD）方法，以支持绿色分析化学概念。采用 NEMI 和 AGREE 方法评估方法的绿色度概况。
