开发和验证紫外光谱光度测量方法,用于估计植物体配方中纳林根因:实验室间比较,能力和统计分析
Vijay Metkari1, Rohit Shah2, Nitin Salunkhe3
1Department of Pharmaceutics, Adarsh College of Pharmacy, Vita, Vita, Maharashtra, India. vmetkari@yahoo.com.
概括
一种新的紫外线光谱测量方法准确地量化了植物体配方中的naringenin. 这种经过验证的方法可靠用于对宁度的例行实验室分析.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 植物体配方增强了像纳灵宁这样溶解不良的化合物的生物可用性.
- 精确量化naringenin对于质量控制和这些配方的疗效评估至关重要.
研究的目的:
- 开发和验证一种简单,可复制和可靠的紫外光谱光度测量方法,用于植物体配方中纳灵宁的确定.
主要方法:
- 优化甲醇作为一种溶剂,用于在289 nm的光谱分析.
- 方法根据国际协调理事会 (ICH) 的指导方针进行验证,包括线性,特异性,准确性,精度,坚固性和强度.
- 使用Shapiro-Wilk,Shapiro-Francia,Bland-Altman图表,Youden图表,Levey-Jennings图表以及能力分析 (Cp,Cpk) 的统计分析.
主要成果:
- 该方法在2-14μg/ml范围内显示出出色的线性 (相关系数=0.9982),遵循兰伯特-比尔定律.
- 获得了高精度 (99.33-99.75%) 和恢复 (99.48 ± 0.41%).
- 确定了低检测值 (0.54微克/毫升) 和量化值 (1.66微克/毫升).
- 统计分析证实了该方法的可靠性,可重复性和控制性,Cp = 1.03和Cpk = 0.83.
结论:
- 开发的紫外线光谱测量方法得到了验证,并且适合在植物体配方中准确可靠地定量宁素.
- 该方法的稳定性和统计控制使其适用于例行实验室分析.
相关概念视频
01:02Ultraviolet and Visible (UV–Vis) Spectroscopy: Overview
Ultraviolet–visible (UV–visible or UV–Vis) spectroscopy is an analytical technique that investigates the interaction between matter and UV–Vis light within the electromagnetic spectrum. This method is widely used for its versatility, simplicity, and relatively quick data acquisition, making it valuable for both qualitative and quantitative analysis. When UV–Vis radiation passes through a material, molecules absorb light depending on the energy required for electronic transitions. As a result...
01:14UV–Vis Spectrometers
The absorbance of UV and visible (UV–visible) radiations is measured using a UV–visible spectrophotometer. Deuterium lamps, which emit UV radiation, and tungsten lamps, which produce radiation in the visible region, are used as light sources in UV–visible spectrophotometers. A monochromator or prism is used for diffraction grating, i.e., to split the incoming radiation into different wavelengths. A system of slits is used to focus the desired wavelength on the sample cell. Samples for...
01:27Microbial Growth Measurement: Indirect Methods
Estimating microbial growth is essential for understanding population dynamics and environmental adaptations. Indirect methods provide valuable insights by measuring parameters such as turbidity, metabolic activity, and biomass, enabling efficient and reproducible assessments.During exponential growth, microbial cells scatter light proportionally to their biomass, a principle used in turbidity measurements. About one million cells per milliliter produce detectable scattering, which a...