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The compounding of injectable cancer drugs for clinical trials often requires specific procedures, with limited access to the starting materials and especially the active compound. These characteristics prevent the application of qualitative or quantitative analyses and quality control techniques. Hence, for some very complex compounding operations, double visual inspection is considered to be less reliable, more time-consuming and more human-resource-intensive than other methods. The compounding team at Lille University Hospital (Lille, France) has equipped one of its preparation areas with a new device: augmented reality (AR) eyewear connected to an oncology drug management system, as a support tool for compounding and quality control. The tool has been tested, adapted and improved within the unit and is now used for investigational drug compounding on a routine basis. In a prospective, single-centre study, we evaluated the feasibility of the implementation of this novel AR approach for the compounding of injectable investigational cancer drugs. During the 6-month study period, 564 clinical trial compounding operations were performed with the AR eyewear. The proportion of poor-quality photos taken with the AR eyewear fell over time, as users became more familiar with the tool. A user satisfaction survey highlighted a very high level of uptake and a wish to broaden the scope of the compounding performed with AR support. The AR eyewear constitutes an innovative, cost-effective tool that increased the level of safety without disrupting the unit's operating procedures. The tool's flexibility enabled its integration into a variety of working environments. The various improvements now being developed should help to further boost the added value of this novel device.

In the last decades, tranexamic acid (TXA) has emerged as an essential tool in blood loss management in obstetrics. TXA prophylaxis for postpartum haemorrhage (PPH) has been studied in double-blind, placebo-controlled, randomized clinical trials (RCTs). Given the small observed preventive effect, the systematic use of TXA for vaginal and/or caesarean deliveries remains controversial. The result of a pharmacokinetic modelling suggests that relative to intravenous administration, intramuscular administration may be an equally effective alternative route for preventing PPH and may enable access to this drug in low-resource countries. Prophylaxis is currently studied in high-risk populations, such as women with prepartum anaemia or placenta previa. TXA effectively reduces blood loss and PPH-related morbidity and mortality during active PPH, as demonstrated by high-grade evidence from large RCTs. The drug has a good safety profile: in most cases, only mild gastrointestinal or visual adverse events may be observed. TXA use does not increase the risk of serious adverse events, such as venous or arterial thromboembolism, seizures, or acute kidney injury. The TRACES in vivo analysis of biomarkers of TXA's antifibrinolytic effect have suggested that a dose of at least 1 g is required for the treatment of PPH. The TRACES pharmacokinetic model suggests that because TXA can be lost in the haemorrhaged blood, a second dose should be administered if the PPH continues or if severe coagulopathy occurs. Future pharmacodynamic analyses will focus on the appropriateness of TXA dosing regimens with regard to the intensity of fibrinolysis in catastrophic obstetric events., Competing Interests: Conflicts of interest The authors declare that the French Ministry of Health and French Drug Safety Agency funded the studies related in this review., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: The optimal dose of tranexamic acid to inhibit hyperfibrinolysis in postpartum haemorrhage is unclear. Tranexamic Acid to Reduce Blood Loss in Hemorrhagic Cesarean Delivery (TRACES) was a double-blind, placebo-controlled, randomised, multicentre dose-ranging study to determine the dose-effect relationship for two regimens of intravenous tranexamic acid vs placebo., Methods: Women experiencing postpartum haemorrhage during Caesarean delivery were randomised to receive placebo (n=60), tranexamic acid 0.5 g (n=57), or tranexamic acid 1 g i.v. (n=58). Biomarkers of fibrinolytic activation were assayed at five time points, with inhibition of hyperfibrinolysis defined as reductions in the increase over baseline in D-dimer and plasmin-antiplasmin levels and in the plasmin peak time., Results: In the placebo group, hyperfibrinolysis was evidenced by a mean increase over baseline [95% confidence interval] of 93% [68-118] for D-dimer level at 120 min and 56% [25-87] for the plasmin-antiplasmin level at 30 min. A dose of tranexamic acid 1 g was associated with smaller increases over baseline (D-dimers: 38% [13-63] [P=0.003 vs placebo]; plasmin-antiplasmin: -2% [-32 to 28] [P=0.009 vs placebo]). A dose of tranexamic acid 0.5 g was less potent, with non-significant reductions (D-dimers: 58% [32-84] [P=0.06 vs placebo]; plasmin-antiplasmin: 13% [18-43] [P=0.051]). Although both tranexamic acid doses reduced the plasmin peak, reduction in plasmin peak time was significant only for the 1 g dose of tranexamic acid., Conclusions: Fibrinolytic activation was significantly inhibited by a dose of intravenous tranexamic acid 1 g but not 0.5 g. Pharmacokinetic-pharmacodynamic modelling of these data might identify the best pharmacodynamic monitoring criteria and the optimal tranexamic acid dosing regimen for treatment of postpartum haemorrhage., Clinical Trial Registration: NCT02797119., (Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background & Aims: The use of long-term taurolidine locks (LTTL) seems to be effective in preventing catheter-related blood stream infections (CRBSI), especially in patients on home parenteral nutrition (HPN). This work targets the cost-effectiveness of LTTL in a cohort of adult HPN patients., Methods: A monocentric mirror-image design study was conducted in our referral centre among long-term HPN patients experiencing recurrent CRBSI. From 7th January 2011, LTTL were started after the third CRBSI episode within 12 months. CRBSI data was prospectively collected until 7th January 2013, in the same way as it had retrospectively been done before initiating LTTL. A cost-effective analysis was conducted to estimate the incremental costs and effects on CRBSI with LTTL. The efficacy of LTTL on CRBSI rate was assessed over 1000 days of catheter use., Results: A total of 31,100 catheter days were analysed in 37 patients (median [interquartile range (IQR)]) aged 58 [42-68] years. The mean ± SD proven CRBSI rate was 3.18 ± 3.51 per 1000 catheter days before the introduction of LTTL and 0.39 ± 1.50 per 1000 catheter days after its introduction (p < 0.0001). Considering both proven and probable CRBSI requiring hospital management, LTTL reduced by (mean [bootstrap CI 95%]) -2.63 [-3.26 to -2.06] infections per patient (from 2.89 [2.31 to 3.49] before to 0.26 [0.13 to 0.41] after) as well as incremental costs by -7 258 [-10 450 to -4 016] € (from 11 176 [8 004 to 14 968] € before to 3 918 [2 390 to 5 445] € after)., Conclusion: Implementing LTTL to prevent recurrent CRBSI is cost-effective by dramatically decreasing their incidence., Competing Interests: Conflict of interest The authors declare that they have no conflict of interest concerning this article., (Copyright © 2021 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

In this study, a capillary electrophoresis-tandem mass spectrometry method combining efficient separation and sensitive detection has been developed and validated, for the first time, to quantify acetaminophen and five of its metabolites in urine samples. Optimization of the method has led us to perform detection in positive ESI mode using MeOH-ammonium hydroxide (0.1%) (50:50, v/v) as sheath liquid. Moreover, optimal separation has been obtained in less than 9 min after anodic injection, using an ammonium acetate solution (40 mM, pH 10) as BGE. It was shown that the dilution solvent and the dilution factor to use for sample preparation are critical parameters to avoid peak splitting, to gain in sensitivity and then to obtain an effective analysis method. While a 200-fold factor dilution was shown to be suitable for quantitation of acetaminophen, acetaminophen mercapturate, acetaminophen sulfate and acetaminophen glucuronide, a 20-fold dilution was finally selected for methoxy-acetaminophen and 3-methylthioacetaminophen analysis, thus requiring two successive analyses to be carried out in order to quantify all metabolites. Hyphenation of CE with MS/MS versus UV permits to improve LOQ (10-20-fold factor with respect to previous works for acetaminophen, acetaminophen sulfate and acetaminophen glucuronide). Moreover, use of CE versus HPLC, permits to quantify two additional metabolites, i.e. 3-methylthio-acetaminophen and methoxy-acetaminophen. The method has been validated using the accuracy profile approach with a total error (accuracy) included in the ± 20% range. Thereby, the method allows the quantitation of acetaminophen and acetaminophen mercapturate in the range (0.1-1 mg mL -1 ), and of acetaminophen sulfate, methoxy-acetaminophen, acetaminophen glutathione and 3-methylthio-acetaminophen in the ranges (0.5-5 mg mL -1 ), (0.025-0.4 mg mL -1 ), (9.22-30 mg mL -1 ) and (0.073-0.4 mg mL -1 ), respectively. The method was finally applied to the analysis of urine samples of eighteen patients belonging to three different inclusion groups of the ongoing clinical trial, demonstrating that the method is suitable to highlight different metabolic profiles. This work will be subsequently extended to the analysis two hundred and seventy urine samples from patients included in a clinical trial dedicated to the study of acetaminophen metabolism changes after hepatic resection., (Copyright © 2019 Elsevier B.V. All rights reserved.)

ROLE OF THE HOSPITAL PHARMACIST IN THE MANAGEMENT OF A CATEGORY OF ADVANCED THERAPY MEDICINAL PRODUCT: CHIMERIC ANTIGEN RECEPTOR T-CELLS: Chimeric Antigen Receptor T-cells (CART) belongs to a new class of medicine, Advanced Therapy Medicinal Product, such as define by the European Regulation 1394/2007, and more exactly to the category of gene therapy medicinal product. Their status of medicine, as well as genetically modified organisms, imposes a particular circuit at hospital while maintaining a way over the Hospital Pharmacy. The manipulation of genetically modified cells is not usual in pharmacy. It requires, besides the acquisition of new skills, a not insignificant reorganization of the teams and the rooms of the pharmacy as well as an adapted training of the staff. A good communication is essential between the various actors of the circuit. The hospital pharmacist plays a key role in the implementation of a circuit adapted to this new type of medicine. This article aims to identify the roles of the hospital pharmacist and more generally of the pharmacy in the management of CART. We shall detail the specificities of this type of medicine in every stage of the circuit and the adaptations necessary to realize to guarantee the quality and the safety of the treatment by CART. Beyond the implementation of the circuit in the hospital, the pharmacist has an important role to be played in the follow-up of the patients after administration in view of the complexity of the side effects and a certain role in the training of the teams to this new medicine. Cet article fait partie du numéro supplément Les cellules CAR-T : une révolution thérapeutique ? réalisé avec le soutien institutionnel des partenaires Gilead : Kite et Celgene., (© 2018 Société Française du Cancer. Publié par Elsevier Masson SAS. Tous droits réservés.)

Ibrutinib is an orally administered first-in-class irreversible Bruton's tyrosine kinase (BTK) covalent inhibitor for the treatment of patients with B-cell malignancies. Several isolated clinical observations reported its efficacy in central nervous system dissemination. Herein, we described the development and validation of an ultra-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) procedure for the quantification of ibrutinib and its active metabolite PCI-45227 in cerebrospinal fluid (CSF). This is the first complete validated method for quantification of ibrutinib and PCI-45227 in CSF. The compounds were eluted on a Waters BEH C18 column (50.0 × 2.1 mm; 1.7 μm) using a gradient elution with a mobile phase composed of ammonium formate buffer 5 mM pH 3.2 and acetonitrile +0.1% formic acid with a flow rate of 400 μL·min -1 . Two deuterated internal standards were used to obtain the most accurate quantification. The CSF samples were prepared by a simple and rapid dilution. The method was validated by testing the selectivity, response function, intra-day and inter-day precisions, trueness, limits of detection (LOD) and lower limits of quantification (LLOQ). The validation results proved that the methods were suitable to quantify ibrutinib and PCI-45227 in real biological CSF samples from 0.50 (ibrutinib) or 1.00 (PCI-45227) to 30.00 ng·mL -1 . Furthermore, the developed method was adapted to allow the quantification of both compounds in plasma and the results were compared to those reported in literature. The plasmatic samples were treated by protein precipitation and the method was validated to quantify ibrutinib and PCI-45227 in real biological plasmatic samples from 5.00 to 491 ng·mL -1 . Lastly, for both matrices, accuracy profiles were plotted from the trueness and precision results using a 20% α-risk (β = 80%) and the tolerance intervals were comprised within the acceptance limits fixed at ±25% for the LLOQ and ±15% for the other concentrations. Finally, these methods were successfully applied to quantify ibrutinib and PCI-45227 in real human CSF and plasma samples., (Copyright © 2018. Published by Elsevier B.V.)

To meet new regulations, alternative plasticizers to di(2-ethylhexyl) phthalate (DEHP) are now commonly used in the manufacturing of medical devices. These are: acetyl tri-n-butyl citrate (ATBC), bis (2-ethylhexyl)adipate (DEHA), dioctyl terephtalate (DEHT), di-isononylphtalate (DINP), diisononylcyclohexane-1.2-dicarboxylate (DINCH) and trioctyltrimellilate (TOTM). An HPLC-UV analysis was previously developed to characterize four of them. However, two compounds were systematically co-eluated: DEHP with DEHA and DEHT with DINP. The first derivative of UV spectra and photodiode array detection allow the quantification of DEHA and DINP. Moreover, for each plasticizer, maximum wavelength absorbance was chosen to be as specific as possible. Quantification ranged from 0.3 to 750µg/mL according to the plasticizer. The assays were validated by analysis of variance. Our method was validated by determining the following parameters: specificity, linearity, limits of detection and quantification. The relative biases were inferior to 5% for ATBC, DEHP, DEHA and DINCH and inferior to 10% for DEHT, DINP and TOTM. Plasticizers were extracted with tetrahydrofuran and methanol. The developed method was then used to determine the composition of plasticizers in several medical devices used in clinical service. The major plasticizers were quantified from 19% to 40% w/w, traces of DEHT were found in six medical devices and DEHP in five., (Copyright © 2016 Elsevier B.V. All rights reserved.)

A wide variety of medical devices (MDs) used in hospitals are made of flexible plasticized polyvinylchloride (PVC). Different plasticizers are present in variable amounts in the PVC matrix of the devices and can leach out into the infused solutions and may enter into contact with the patients. The ARMED 1 project aims to assess the migration of these plasticizers from medical devices and therefore the level of exposure in patients. For the first task of the project, eight methods were developed to directly detect and quantify the plasticizers in the PVC matrix of the MDs. We compared the overall performances of the analytical methods using standardized and validated criteria in order to provide the scientific community with the guidance and the technical specifications of each method for the intended application. We have shown that routine rapid screening could be performed directly on the MDs using the FTIR technique, with cost-effective analyses. LC techniques may also be used, but with limits and only with individual quantification of the main plasticizers expected in the PVC matrix. GC techniques, especially GC-MS, are both more specific and more sensitive than other techniques. NMR is a robust and specific technique to precisely discriminate all plasticizers in a MD but is limited by its cost and its low ability to detect and quantify plasticizer contamination, e.g. by DEHP. All these results have been confirmed by a real test, called the " blind test " carried out on 10 MD samples., (Copyright © 2016 Elsevier B.V. All rights reserved.)

Searching for alternatives to di-(2-ethylhexyl)-phthalate, a plasticizer that has been widely used in the manufacturing of PVC medical devices, has become a major challenge since a European regulation underlined some clinical risks. The aim of this study is to develop an HPLC-UV method to quantify the currently used alternative plasticizers to DEHP. Five plasticizers, acetyl tributyl citrate, di-(2-ethylhexyl)-phthalate, di-(ethylhexyl)-terephthalate, di-isononyl-1,2-cyclohexane-dicarboxylate, and trioctyl trimellitate, were separated on a C8 stationary phase (2.6 μm, 100 mm × 4.6mm) under gradient elution in 13 min. They were detected at 221 nm leading to a quantification threshold from 0.3 to 750 μg/mL as a function of the plasticizer. Within-day and between-day precisions were inferior to 0.9% and 18%, respectively. The assays were validated according to the accuracy profile method. Plasticizers were extracted from PVC-tubing by dissolving PVC in THF then precipitating it in methanol with a yield of over 90% for each plasticizer. This assay could feasibly be used to quantify plasticizers in PVC medical devices., (Copyright © 2014 Elsevier B.V. All rights reserved.)

This work was dedicated to the development of a simple and direct multivariate UV spectrophotometric method for the simultaneous determination of three antiemetic drugs (ondansetron, dexamethasone and aprepitant) in a new organogel formulation developed for their simultaneous transdermal administration. This method that does not require separation of the drugs and sophisticated instrument will permit to control quality of this new transdermal form both during the optimization step and for a further routine control of this preparation at the pharmacy department of the hospital. Hence, a partial least squares regression model using the spectral data record from 260 to 288 nm and 5 components, has firstly been validated thanks to the evaluation of the REP% (under 7.9%) and secondly using an accuracy profile approach (acceptance limit of ±10%). Thereby, the method allows the quantitation of the drugs in the ranges (5-15 mg L(-1)), (4-8 mg L(-1)) and (20-50 mg L(-1)) for ondansetron, dexamethasone and aprepitant, respectively. An HPLC/UV reference method has also been developed. Optimal separation (2.52

Objectives: Noradrenaline (NA) can be infused through various systems including single or double syringe pumps. The aim of this study was to define the best and most efficient infusion system in an emergency context., Study Design: This was a retrospective clinical study based on the analysis of patients' hemodynamic data., Patients and Method: Three infusion lines used presently in our postoperative ICU were compared through a retrospective clinical study: an NA syringe pump at 2mL/h and a saline carrier solution syringe pump at 8mL/h (infusion system 1- IS1) or 5mL/h (IS2), both connected to a very low dead-space volume set (V=0.046mL); IS3 with the same NA syringe at 2mL/h directly connected to the central venous catheter. Mean arterial pressure (MAP) was obtained from retrospective data analysis of ICU patients with postoperative septic shock criteria. Infusion systems were compared according to the time required to reach an MAP greater than 65mmHg after the onset of infusion., Results: Data from 37 patients was analysed. The MAP objective was attained in 14:00 minutes (9:20 - 26:10, n=15) with IS1, in 19:10 minutes (12:20 - 27:20, n=13) with IS2 and in 34:10 minutes (23:10 - 62:30, n=9) with IS3 (P=0.00032)., Conclusion: The use of a double syringe pump system associated with a very low dead-space volume infusion set appears to be the most appropriate system for NA infusion., (Copyright © 2013 Société française d’anesthésie et de réanimation (Sfar). Published by Elsevier SAS. All rights reserved.)

Objective: Stopping and restarting carrier fluid flow and performing simultaneous drug infusions can lead to hazardous disturbances in drug delivery. The present study was designed to assess in vitro whether using a multi-lumen infusion access device could prevent noradrenaline disturbances., Study Design: In vitro laboratory work., Methods: Two infusion devices were studied: a standard device with a four-port manifold and a 150cm extension line and a nine-lumen infusion device (Edelvaiss-Multiline(®)) with eight accesses connected to nine separate lumens in a single tube of 150cm: seven accesses connected to seven peripheral lumens and one for the carrier fluid access connected to two lumens. Two experimental protocols of noradrenaline infusion were made: (a) drug flow rate change and (b) stop-and-go carrier fluid flows. Two parameters were studied: drug mass flow rate and flow change efficiency (FCE) calculated from the ratio of the area under the experimental mass flow rate curve to the area under the theoretical instantaneous mass flow rate curve., Results: Variations in noradrenaline mass flow rate were more rapid with the Edelvaiss-Multiline(®) when the noradrenaline infusion rate was increased or decreased. FCE was significantly different from one infusion device to the other during both noradrenaline flow rate increase (standard vs. nine-lumen: 58% vs. 84%; P=0.008) and decrease (175% vs. 108%; P=0.008). Decreased drug delivery after stopping carrier fluid flow (standard vs. nine-lumen: 21% vs. 98%; P=0.008) and sudden temporary increases on resumption (253% vs. 103%; P=0.008) were reduced in magnitude and duration when using the Edelvaiss-Multiline(®) with a significant difference in FCE between the two infusion devices., Conclusions: Using the nine-lumen infusion device reduces drug delivery disturbances during continuous intravenous infusion., (Copyright © 2013 Société française d’anesthésie et de réanimation (Sfar). Published by Elsevier SAS. All rights reserved.)

The restoration of patients' mean arterial pressure after ineffective fluid resuscitation is obtained by vasopressive treatment such as norepinephrine. However, no guidelines exist concerning a norepinephrine infusion method: whether it be the norepinephrine concentration in the syringe, single or double pump administration via a carrier such as an isotonic saline solution, or use of minimized dead-volume extension sets. We present the case of a female patient requiring norepinephrine treatment, who quickly suffers a major haemodynamic incident (a sudden rise in systolic blood pressure above 220 mmHg associated with tachycardia up to 189 b/min). The main causes of this incident are discussed and infusion parameters considered with a view to developing an optimal infusion method for a drug with a specific therapeutic index., (Copyright © 2012 Société française d’anesthésie et de réanimation (Sfar). Published by Elsevier SAS. All rights reserved.)

The complexation of risperidone (Risp) and 9-hydroxyrisperidone (9-OH-Risp), atypical antipsychotics, with seven cyclodextrins (CDs) of pharmaceutical interest (native and hydroxypropylated (HP) alpha-, beta-, gamma-CDs and methyl (Me)-beta-CD) was studied by affinity capillary electrophoresis (ACE) and nuclear magnetic resonance spectroscopy (NMR) for acidic pH 2.5 and physiological pH 7.4. The 1:1 stoichiometry of the complexes was established by (1)H NMR spectroscopy using the continuous variation method developed by Job. The apparent binding constants of the 14 complexes at both pH were determined by ACE through the linear Scott's plots. The NMR spectroscopy investigation of the binding constants was achieved for the two CDs allowing the highest complexation: the beta-CD and Me-beta-CD. Both ACE and NMR spectroscopy studies provide similar conclusions by considering the influence of the 9-hydroxylation, the influence of the CD substitution and the influence of the pH. Moreover, the NMR spectroscopy results have allowed to suppose a pH-dependent inclusion mechanism. A thermodynamic study was then performed by ACE at both pH for the Risp.Me-beta-CD and 9-OH-Risp.Me-beta-CD complexes: the opposite signs of the entropic change (DeltaS degrees <0 at pH 2.5 and DeltaS degrees >0 at pH 7.4) confirms the influence of the pH on the complexation mechanism and the possible difference in the depth of the analyte inclusion in the hydrophobic cavity of the CD. Last, the two-dimensional ROESY (rotating-frame Overhauser spectroscopy) ((1)H-(1)H) and HOESY (heteronuclear Overhauser effect spectroscopy) ((19)F-(1)H) experiments have proved the inclusion of the aromatic part of the Risp and 9-OH-Risp in the hydrophobic CD cavity and lead us to propose a model of complexation.

Objective: This work consisted of the assessment of humidification parameters and flow resistance for different heat and moisture exchanger filters (HMEF) used in intensive care unit. Four electrostatic HMEF were assessed: Hygrobac S (Tyco); Humidvent compact S (Teleflex); Hygrovent S/HME (Medisize-Dräger); Clear-Therm+HMEF (Intersurgical)., Material and Methods: Humidification parameters (loss of water weight, average absolute moisture [AAM], absolute variation of moisture) have been evaluated on a bench-test in conformity with the ISO 9360: 2000 standard, for 24h with the following ventilatory settings: tidal volume at 500 ml, respiratory rate at 15 c/min, and inspiration/expiration ratio at 1:1. The flow resistance of HMEFs assessed using the pressure drop method was measured before and after 24h of humidification for three increasing air flows of 30, 60, and 90 l/min., Results: All the HMEFs allowed satisfactory level of humidification exceeding 30 mgH(2)O/l. The less powerful remained the Clear-Therm. Concerning HMEFs flow resistance, results showed a pressure drop slightly more important for the Hygrobac S filter as compared with other filters., Conclusion: This test showed differences between the HMEFs for both humidification and resistance parameters. When compared to the new version of the standards, HMEFs demonstrated their reliability. However, evolution of humidification and flow resistance characteristics over 24h showed a structural degradation of HMEFs, limiting their use over a longer period.

The HPLC semipreparative enantioseparation of 9-hydroxyrisperidone (9-OHRisp) was studied by optimizing various experimental conditions: the nature of the chiral stationary phase (CSP), mobile phase composition, temperature and analyte loading. This semipreparative enantioseparation was successfully completed using the polysaccharide Chiralcel OJ chiral stationary phase and a n-hexane/ethanol/methanol (50/35/15, v/v/v) ternary mobile phase. To assess the enantiomeric purity of both isolated isomers, three analytical methods using UV detection were developed and validated: one CE method using dual cyclodextrin mode and two HPLC methods using either the Chiralcel OJ CSP in normal-phase mode or the alpha-acid glycoprotein (alpha-AGP) CSP in reversed-phase mode. The three methods make it possible to obtain excellent enantioseparations (R(s) >3) with analysis times lower than 15 min, and the calculated limits of detection allow for the determination of minor enantiomeric impurities (0.1%). Enantiomeric purity obtained for dextrorotatory and levorotatory enantiomers was superior to 99.9% and equal to 98.9%, respectively, which proved the success of the semipreparative enantioseparation. A brief comparison of the performances of the analytical methods completes this work.