Abstract A robust and reliable Diffuse Reflectance Infrared Fourier Transform Spectroscopy (DRIFTS) method was developed and validated for the quantification of a novel antipsychotic agent pimavanserin tartarate. A holistic novel concept of Analytical Procedure Development (APD) was implemented for establishing the robust nature of the method while aiming to achieve analytical excellence. Experiment room temperature (°C), number of scans and resolution (cm−1) were identified as the critical method variables for quantitative measurements performed in the 1614 cm−1 region for the carbonyl i.e. C O group stretching mode absorption. Infrared absorption intensity was considered as the critical analytical attribute of the analytical method. Risk-based investigation and optimization exercises revealed that resolution was found significantly affecting the measurements and control strategy was defined to control the variation due to it. The optimized method was validated as per ICH norms for Beer’s range (1.0–3.5 μg/mg), accuracy (>100 %) and precision (RSD

中文翻译：

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化学计量辅助漫反射红外傅里叶变换光谱 (DRIFTS) 方法用于定量药物中的新型抗精神病药物：ICH Q 14 概念的案例研究

摘要 开发并验证了一种稳健可靠的漫反射红外傅里叶变换光谱 (DRIFTS) 方法，用于量化新型抗精神病药酒石酸匹马万色林。实施了分析程序开发 (APD) 的整体新颖概念，以建立该方法的稳健性，同时旨在实现卓越的分析。实验室温 (°C)、扫描次数和分辨率 (cm-1) 被确定为在 1614 cm-1 区域进行羰基（即 CO 基团伸缩模式吸收）定量测量的关键方法变量。红外吸收强度被认为是分析方法的关键分析属性。基于风险的调查和优化练习表明，发现分辨率显着影响了测量，并定义了控制策略以控制由此引起的变化。优化的方法按照 ICH 规范对 Beer 的范围 (1.0–3.5 μg/mg)、准确度 (>100%) 和精密度 (RSD) 进行了验证