研究目的
To develop a simple, sensitive, precise, reproducible, and validated UV spectrophotometric method for the determination of vincristine (VCR) and vinblastine (VLB) in pure and dosage forms.
研究成果
The developed spectrophotometric method is simple, rapid, reproducible, accurate, precise, and cost-effective for quantifying VCR and VLB in pure substances and dosage forms. It offers an alternative to more complex and expensive methods like HPLC, making it suitable for routine quality control in laboratories, with validation confirming compliance with pharmacopeial standards.
研究不足
The method relies on UV absorption, which may be affected by impurities or matrix effects in complex samples. It is validated for concentrations between 5-50 μg/ml and may not be suitable for very low concentrations below the LOD. The use of commercial dosage forms instead of pure standards could introduce variability. Robustness testing showed sensitivity to pH changes, requiring careful control of solvent conditions.
1：Experimental Design and Method Selection:
The method is based on the solubility of VCR and VLB in purified water and their UV absorption characteristics at specific wavelengths (295 nm for VCR and 268 nm for VLB), adhering to Bouguer-Lambert-Beer's law over a concentration range of 5-50 μg/ml.
2：Sample Selection and Data Sources:
Commercial dosage forms of VCR and VLB sulfates (e.g., Vincristine-TEVA, Vinblastine-LANS?) were used as standard samples due to low availability and high cost of pure substances.
3：List of Experimental Equipment and Materials:
Equipment includes a Hitachi ratio beam spectrophotometer U-1900, pH meter model pH-121, medical water distillation apparatus AE-25, quartz cells, and software (Microsoft Excel, StatSoft Statistica, Origin Pro-2015). Materials include purified water, buffer solutions (pH 3-10), and analytical grade chemicals.
4：5). Materials include purified water, buffer solutions (pH 3-10), and analytical grade chemicals. Experimental Procedures and Operational Workflow:
4. Experimental Procedures and Operational Workflow: Stock solutions were prepared by dissolving lyophilized drugs in purified water to 100 μg/ml. Standard solutions (5-50 μg/ml) were prepared by dilution. UV absorption spectra were recorded from 190 to 400 nm using a 10 mm quartz cell at room temperature. Calibration curves were constructed, and validation was performed for specificity, linearity, precision, accuracy, LOD, LOQ, and robustness.
5：Data Analysis Methods:
Linear regression was used to analyze calibration data, with parameters calculated using software. Statistical validation included recovery studies, RSD calculations, and compliance with pharmacopeial guidelines.
独家科研数据包，助您复现前沿成果，加速创新突破
获取完整内容
