拉曼光谱法用于对Febuxostat活性制药成分固体剂型的定量分析
Gull Rimsha1, Muhammad Shahbaz1, Muhammad Irfan Majeed1
1Department of Chemistry, University of Agriculture Faisalabad, Faisalabad 38000, Pakistan.
ACS omega
|November 16, 2023
概括
拉曼光谱学有效地识别和量化固体剂型的费布克索斯塔特 (API). 该技术使用多变量分析,准确预测各种配方中的药物度,有助于质量控制.
科学领域:
- 分析化学 分析化学
- 制药科学 制药科学
- 频谱学是一种光谱学.
背景情况:
- 费布克索斯塔特是一种用于治疗痛风和高尿血的药物.
- 固体剂型中活性药物成分 (API) 的准确量化对于药物的质量和疗效至关重要.
- 药物配方的表征需要可靠的分析方法.
研究的目的:
- 通过拉曼光谱学来描述和量化固体剂量形式的febuxostat.
- 为了评估多变量数据分析 (PCA和PLSR) 对于febuxostat分析的实用性.
- 为了比较自制的febuxostat配方与商用产品.
主要方法:
- 用不同的API度制备febuxostat配方.
- 使用拉曼光谱学的配方分析.
- 主要组件分析 (PCA) 用于定性分析的应用.
- 部分最小平方回归 (PLSR) 的应用,用于定量分析.
主要成果:
- PCA有效地监测了不同的固体剂型.
- 在预测API度方面,PLSR实现了高灵敏度 (98%) 和选择性 (99%).
- PLSR模型在校准 (2.9033) 和验证 (1.35) 中显示了较低的平方根平均误差 (RMSE).
- 拉曼光谱学成功地比较了内部和商业的febuxostat片.
结论:
- 拉曼光谱是一种可靠的技术,用于识别和量化febuxostat API.
- 多变量分析增强了拉曼光谱用于制药分析的能力.
- 这种方法为febuxostat固体剂型的质量控制提供了有价值的工具.
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