Implementation of real-time identification analysis and quantification of chemotherapies preparations with a Multispec® analyser

Bazin, Christophe; Vieillard, Victoire; Astier, A.; Paul, Muriel

doi:10.1016/j.pharma.2013.09.006

Cited by 21 publications

(20 citation statements)

References 12 publications

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“…Introduite récemment, cette technique a été utilisée pour élucider deux non conformités. Pour la première non-conformité, la colonne utilisée est de type Uptisphere HDO (Interchim, Montluçon, France), de 4,6 mm de diamètre, de 250 mm de longueur, contenant une phase stationnaire de gel de silice greffé phényl héxyl avec un taux de carbone de 16 …”

Section: Technique De « Recours » (Clhp-dad)unclassified

“…L'analyse de la littérature montre qu'il existe actuellement en [ ( F i g u r e _ 2 ) T D $ F I G ] de différencier certaines paires critiques telles que doxorubicine/daunorubicine, ifosfamide/cyclophosphamide [9]. Les seules molécules posant encore problème sont doxorubicine/ épirubicine [16] bien que certaines équipes aient réussi à les différencier [18] Cette méthode permet aussi de contrôler la nature du solvant de reconstitution NaCl 0,9 % ou glucose 5 %. Bazin et al [17] Quel est l'impact financier du contrôle ?…”

Section: Retrait De Lotunclassified

“…Le prologiciel comporte deux modules : Multispec W Analyse qui permet l'acquisition et Multispec W Librairie et Quantification qui permet le traitement de l'information. Ce système existe dans un nombre important de laboratoires de PUI (au moins 18[15]) et son application au contrôle des cytotoxiques est largement répandue dans la littérature[7,9,[15][16][17][18]. Les principaux avantages de ce système en comparaison à la FIA-DAD sont apportés par l'IR qui est une méthode d'analyse structurale supérieure à l'UV-visible.…”

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Contrôle analytique des préparations cytotoxiques : bilan de 7ans d’activité et perspectives

Delis

Vigneron

Sobalak

et al. 2015

Le Pharmacien Hospitalier et Clinicien

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Section: Technique De « Recours » (Clhp-dad)unclassified

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Contrôle analytique des préparations cytotoxiques : bilan de 7ans d’activité et perspectives

Delis

Vigneron

Sobalak

et al. 2015

Le Pharmacien Hospitalier et Clinicien

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“…Two different types of analytical techniques can be employed to determine antineoplastic drugs in pharmaceutical formulations: spectroscopic and separation techniques. The first are mainly based on ultraviolet (UV), infrared, or Raman spectroscopy . A sample of the pharmaceutical formulation (or directly the full pharmaceutical formulation in the case of Raman spectroscopy) is directly analyzed without pretreatment, except a dilution to reach the calibration concentration range.…”

Section: Introductionmentioning

confidence: 99%

Determination of 16 antineoplastic drugs by capillary electrophoresis with UV detection: Applications in quality control

Guichard

Ogereau²,

Falaschi³

et al. 2018

Electrophoresis

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Two capillary electrophoresis (CE) methods were developed for the analysis of 16 antineoplastic drugs contained in injectable pharmaceutical formulations. A capillary zone electrophoresis (CZE) method coupled to UV was developed with a background electrolyte (BGE) made of a 100 mM phosphate buffer at pH 2.5 containing 50% v/v of acetonitrile and dynamic coating of capillaries with Ceofix®. This method allowed the analysis of doxorubicin, epirubicin, idarubicin, daunorubicin, irinotecan, topotecan, vincristine, vindesine, vinblastine, and vinorelbine in less than 8 min. A micellar electrokinetic chromatography (MEKC) method coupled to UV was also developed for the determination of methotrexate, pemetrexed, etoposide, etoposide phosphate, fludarabine phosphate, and 5-fluorouracil. A run time of 16 min was obtained with a BGE made of 50 mM borate buffer at pH 9.2 with 80 mM of sodium dodecyl sulfate (SDS) and 20% v/v of acetonitrile. For both methods, the applied voltage was 30 kV and the sample injection was performed in the hydrodynamic mode. All analyses were carried out in fused silica capillaries with an internal diameter of 50 μm and a total length of 64.5 cm. Both methods were validated and trueness values between 99.4 and 101.3% were obtained with repeatability and intermediate precision values of 0.5-1.8% for all drugs. These methods were found appropriate for controlling injectable pharmaceutical formulations containing antineoplastic drugs and successfully applied in quality control.

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“…However, this method has some inconvenient like technical and time constraints which can be a limiting factor for the integration of an analytical control in real time. Other techniques were developed to allow faster controls: high-performance thin layer chromatography (HPTLC) [12], automaton coupling ultraviolet (UV) and Fourier-Transformed Infrared spectroscopy (UV/vis-FTIR) (Multispec ® ) [13,14] or Raman spectroscopy (UV-Raman) (QCPrep ® ) [15][16][17][18]. HPTLC concept is interesting because it allows significant time savings by successfully analyzing more than 20 samples in one run.…”

Section: Introductionmentioning

confidence: 99%

Analytical Control of Pediatric Chemotherapy Preparations with a UV-Raman Automaton: Results After 18 Months of Implementation and Development of A Suitable Method for Low Volume Preparations

Chouquet

Benoît

Morand

2017

Pharmaceutical Technology in Hospital Pharmacy

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AbstractBackgroundIn France, control of chemotherapy preparations is highly recommended. Analytical control is a method of choice for identifying and quantifying drugs. Pediatric preparations, which often contain small quantities of drugs and are made in low final volumes were until then not analytically controlled. After the development and validation of a new sampling and assaying method for low volume chemotherapy preparations with an UV/Raman automaton (QCPrep +), the quality control results of the preparations intended for the patients were analyzed over a period of eighteen monthsMethodsThe results were studied by type of preparation (low and high volume), per molecule, manipulator, and conformity rates dispersion.ResultsOver the period, 7,548 controls were carried out, representing 87.7% of our production. 75.5% of these controls concerned low-volume preparations (<50mL). The overall conformity rate was 94.4%. The lowest conformity rates were found for vinca alkaloids, methotrexate and some rarely manipulated drugs (cisplatin, decitabine, epirubicin). The study of the results dispersion showed non-conformities increasing with low concentrations, specific to pediatrics. These results show the limits of analytical control for pediatric preparations. The low analytical sensitivity encountered for certain concentrations and drugs requires a complementary quality control tool, like camera or video. However this new analytical method allows us to improve the safety of the injectable chemotherapy circuit.ConclusionYoung patients can benefit from the same level of safety and quality as adult patients. Some critical points could be highlighted: the homogenization of the preparations, the analytical sensitivity of some drugs and human factors. This data allow us to focus our work on staff training, improving our calibration ranges and on the development of complementary control tools.

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Implementation of real-time identification analysis and quantification of chemotherapies preparations with a Multispec® analyser

Cited by 21 publications

References 12 publications

Contrôle analytique des préparations cytotoxiques : bilan de 7ans d’activité et perspectives

Contrôle analytique des préparations cytotoxiques : bilan de 7ans d’activité et perspectives

Determination of 16 antineoplastic drugs by capillary electrophoresis with UV detection: Applications in quality control

Analytical Control of Pediatric Chemotherapy Preparations with a UV-Raman Automaton: Results After 18 Months of Implementation and Development of A Suitable Method for Low Volume Preparations

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