The goal of the current work was to establish a simple, reproducible, and reliable UV spectrophotometric method for determining naringenin in phytosomal formulations. The solvent methanol was optimized and spectrophotometric analysis was carried out at 289 nm. The proposed method was also validated for linearity, specificity, accuracy, precision, ruggedness, and robustness in accordance with the International Council for Harmonisation (ICH). With a correlation coefficient of 0.9982, the concentration of naringenin in the range of 2-14 μg/ml follows Lambert-Beer rule. The accuracy ranged between 99.33 and 99.75%. The predicted percent recovery was found to be 99.48 ± 0.41. It was found that the limits of detection (LOD) and quantification were 0.54 μg/ml and 1.66 μg/ml, respectively. The normality of the data is accepted by the Shapiro-Wilk test (P = 0.9065) and Shapiro-Francia test (W = 0.9866). On the Bland-Altman plot, an acceptable repeatability coefficient was found. The remarkable inter-laboratory repeatability was proved by the Youden plot, which was also utilized to spot random and total errors. Levey-Jennings charts and other control diagrams have demonstrated that the method is statistically controlled. Greater values of Cp (1.03) and Cpk (0.83) were seen in the capability analysis, indicating that the method could analyze the samples reliably and consistently with minimum variation. The validation report demonstrated that the proposed method was appropriate for naringenin detection and analysis in phytosomal formulations, indicating that it can be employed for routine laboratory analysis as well.

中文翻译：

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用于估计植物体制剂中柚皮素的紫外分光光度法的开发和验证：实验室间比较、能力和统计分析。

当前工作的目标是建立一种简单、可重复且可靠的紫外分光光度法来测定植物体制剂中的柚皮素。对溶剂甲醇进行优化，并在289 nm处进行分光光度分析。所提出的方法还根据国际协调委员会 (ICH) 的线性度、特异性、准确性、精密度、耐用性和鲁棒性进行了验证。柚皮素浓度在2-14 μg/ml范围内遵循Lambert-Beer法则，相关系数为0.9982。准确度介于 99.33% 至 99.75% 之间。预测回收百分比为 99.48 ± 0.41。结果发现，检测限 (LOD) 和定量限分别为 0.54 μg/ml 和 1.66 μg/ml。Shapiro-Wilk 检验 (P = 0.9065) 和 Shapiro-Francia 检验 (W = 0.9866) 接受数据的正态性。在 Bland-Altman 图上，找到了可接受的重复性系数。约登图证明了卓越的实验室间重复性，该图也用于发现随机误差和总误差。Levey-Jennings 图和其他控制图已证明该方法是统计控制的。在能力分析中看到较大的 Cp (1.03) 和 Cpk (0.83) 值，表明该方法可以可靠、一致地分析样品，且变异最小。验证报告表明，该方法适用于植物体制剂中柚皮素的检测和分析，表明该方法也可用于常规实验室分析。