Discriminative and Quantitative Analysis of Antineoplastic Taxane Drugs Using a Handheld Raman Spectrometer

被引:16
|
作者
Le, Laetitia [1 ,2 ]
Berge, Marion [2 ]
Tfayli, Ali [1 ]
Prognon, Patrice [1 ,2 ]
Caudron, Eric [1 ,2 ]
机构
[1] Univ Paris Saclay, U Psud, Lip Sys 2, EA7357,UFR Pharm, Chatenay Malabry, France
[2] Hop Europeen Georges Pompidou, AP HP, Pharm Dept, Paris, France
关键词
ANALYTICAL QUALITY-CONTROL; CHEMOTHERAPIES PREPARATIONS; ANTICANCER DRUGS; SFSTP PROPOSAL; SPECTROSCOPY; QUANTIFICATION; HPLC; IMPLEMENTATION; HARMONIZATION; STRATEGIES;
D O I
10.1155/2018/8746729
中图分类号
Q81 [生物工程学(生物技术)]; Q93 [微生物学];
学科分类号
071005 ; 0836 ; 090102 ; 100705 ;
摘要
This study was conducted to evaluate the ability of Raman spectroscopy (RS) to control antineoplastic preparations used for chemotherapy in order to ensure its physical and chemical qualities. Three taxane drugs: cabazitaxel (CBX), docetaxel (DCX) and paclitaxel (PCX) at therapeutic concentration ranges were analyzed using a handheld spectrometer at 785 nm. Qualitative and quantitative models were developed and optimized using a calibration set (n=75 per drug) by partial least square discriminant analysis and regression and validated using a test set (n=27 per drug). All samples were correctly assigned with an accuracy of 100%. Despite optimization, quantitative analysis showed limited performances at the lowest concentrations. The root mean square error of predictions ranged from 0.012 mg/mL for CBX to 0.048 mg/mL for DCX with a minimal coefficient of determination of 0.9598. The linearity range was validated from 0.175 to 0.30 mg/mL for CBX, from 0.40 to 1.00 mg/mL for DCX and from 057 to 1.20 mg/mL for PCX. Despite some limitations, this study confirms the potential of RS to control these drugs and also provides substantial advantages to secure the activity for healthcare workers. As a result of its rapidity and the uncomplicated use of a handheld instrument, RS appears to be a promising method to augment security of the medication preparation process in hospitals.
引用
收藏
页数:7
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