Laboratory of Analytical Chemistry, Faculty of Medicine and Pharmacy of Rabat, Mohamed V University, Rabat, Morocco.
Faculty of Pharmacy, Abulcasis University, Rabat, Morocco.
J Oncol Pharm Pract. 2021 Jan;27(1):99-107. doi: 10.1177/1078155220914721. Epub 2020 Apr 7.
The preparation of anticancer chemotherapy in a hospital must meet several objectives; the first main is the quality, which can be provided by setting up a surveillance system and a quality control of each preparations. The aim of this work is to present a simple, fast and accurate spectrophotometric method for the routine control of cytotoxic preparations.
This is a study carried out in the cytotoxic preparation unit of the university center of Rabat-Sale children's hospital in Morocco. All samples of preparations were collected and analyzed daily on the site. After validation of the analytical method with respect to many parameters such as: linearity, accuracy and precision according to ICH Q2 guidelines, samples of cytotoxic preparations collected were assayed.
The results are satisfactory with good level of exactitude, and high precision.
Compared to other techniques, this method can be considered as a useful alternative in the routine quality control of preparations. It can quickly obtain qualitative and quantitative information with instrumentation and inexpensive reagents.
医院制备抗癌化疗药物必须满足几个目标；首要目标是质量，可以通过建立监控系统和每个制备过程的质量控制来实现。本工作的目的是提出一种简单、快速和准确的分光光度法，用于常规控制细胞毒性制剂。
这是在摩洛哥拉巴特-萨勒儿童医院大学中心的细胞毒性制剂单位进行的一项研究。所有制剂样品均在现场每天收集和分析。在根据 ICH Q2 指南对分析方法的许多参数（如线性、准确性和精密度）进行验证后，对收集的细胞毒性制剂样品进行了检测。
结果令人满意，具有良好的准确度和高精度。
与其他技术相比，该方法可作为制剂常规质量控制的一种有用替代方法。它可以使用仪器和廉价试剂快速获得定性和定量信息。
