Stability and compatibility of cisplatin and carboplatin with PVC infusion bags

The stability of the carboplatin market drug products Ribocarbo 1 and Ribocarbo-L 1 in 0.9% sodium chloride or 5% glucose infusion solution was investigated by HPLC analysis using a Nucleosil-120-5-C18 column, an eluent consisting of methanol and an aqueous solution of H 2 SO 4 (0.001 N with Na 2 SO 4 (0.02 M); 10:90 or 5:95 (v/v)), and UV detection.At room temperature, carboplatin is stable in 0.9% NaCl solution for 1 h only. During the following 168 h, a 10% degradation to cisplatin and the intermediate diamminechloro[O 1 -1-carboxylato-1-carboxycyclobutane]platinum(II) takes place. This reaction is independent of the carboplatin concentration used.Under identical conditions in 5% glucose solution the carboplatin concentrations decrease during 72 h by about 2±3% and by 5±6% after 168 h of storage. At 4 C, a 10 mg/ml solution is stable during the experiment, whereas from a 1 mg/ml carboplatin infusion, 2% of the drug are lost after day 7 and about 3% after day 28. Degradation products were unequivocally identi®ed. The presence of highly toxic carboplatin hydrolysis products, however, could be excluded.

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“…Benaji et al [15] have described a constant concentration of 2.4 mg/ml in PVC bags over a storage period of 9 d at room temperature. Amador et al…”

Section: Stability Of Ribocarbo-l 1 In 5% Glucose Solutionmentioning

confidence: 99%

Investigations on the Stability of Carboplatin Infusion Solutions

Gust

Schnurr

1999

Monatshefte fuer Chemie

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“…CPT is a polar, weakly basic molecule that is stable when stored in the dark at room temperature. 8 A number of methods, including high performance liquid chromatography 9 , atomic absorption spectrometry 10 , inductively coupled plasma-mass spectrometry 11 , X-ray 12 and nuclear magnetic resonance 13 , have been used to assay CPT. More recently, a LC/MS method with a sensitivity (LLOQ of 2 ng/mL) approaching that of atomic absorption spectrometry has been developed for the quantification of CPT in human plasma ultrafiltrates.…”

Section: Introductionmentioning

confidence: 99%

Development and validation of a LC/TOF MS method for the determination of carboplatin and paclitaxel in nanovesicles

Eggers

Raston

et al. 2014

Anal Bioanal Chem

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Carboplatin and paclitaxel co-loaded nanovesicles (CPT-PTX-CLV), a novel intravenous formulation void of cremophor EL, may have significant advantages over conventional carboplatin and paclitaxel formulations with respect to tumor targeting, sustained drug release, reduced toxicity, and synergistic efficacy profiles. The aim of this study was to develop and validate a rapid, specific, sensitive, and reliable liquid chromatography-time of flight-mass spectrometry (LC/TOF MS)-based bioanalytical method for the simultaneous quantification of CPT and PTX in a fetal bovine serum (FBS) vehicle containing the dispersed nanovesicles. The analytes were extracted from FBS by simple protein precipitation, with subsequent separation of CPT and PTX on a Waters HPLC SunFire C18 column at a flow rate of 0.25 ml/min using gradient elution mode. The total analytical time was only 12 min. Detection and quantitation was performed by electrospray ionization (ESI) in the positive ionization mode with selective ion monitoring (SIM) at m/z 310.0152 for CPT and 876.3224 for PTX. The calibration curves were linear over the concentration range of 10-4,000 ng/ml for CPT and 5-2,000 ng/ml for PTX (r (2) > 0.99), with the respective lower limit of quantification (LLOQ) at 10 and 5 ng/ml. The intra- and inter-day precision and accuracy of analysis of the quality control samples at low, medium, and high concentration levels were ≤13.6 % relative standard deviation (RSD) and ≤14.6 % relative errors (RE). The rapid, sensitive, and reproducible LC/TOF MS method may be used to support preclinical and clinical pharmacological studies of the CPT-PTX-CLV administered by injection in animal and human cancer models.

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“…The stability of carboplatin in the presence of chloride ions, provided under perfusion conditions, has been largely studied (Benaji et al, 1994;Valiere et al, 1996;Lederer & Leipzig-Pagani, 1998). The reaction has been shown to produce cisplatin (Curis et al, 2000), which increases the drug toxicity.…”

Section: Introductionmentioning

confidence: 99%

EXAFS characterization of oxaliplatin anticancer drug and its degradation in chloride media

Bouvet¹,

Michalowicz²,

Crauste–Manciet

et al. 2006

J Synchrotron Radiat

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Oxaliplatin is a second-generation platinum-based anticancer drug. Its degradation is studied in solution, in the presence of chloride ions (in neutral or acidic media) in excess. In both cases the degradation product precipitates immediately. The EXAFS spectra of these products show that they are identical. EXAFS modeling and refinement of the first coordination sphere shows that two light atoms are replaced by two chloride ions. The complete refinement of the local structure is possible by studying the multiple-scattering signal. The results show that the main multiple-scattering contribution is due to the binding oxalato group and that the degradation product is [Cl(2)-(diaminocyclohexane)-Pt(II)].

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Stability and compatibility of cisplatin and carboplatin with PVC infusion bags

Cited by 19 publications

References 13 publications

Investigations on the Stability of Carboplatin Infusion Solutions

Investigations on the Stability of Carboplatin Infusion Solutions

Development and validation of a LC/TOF MS method for the determination of carboplatin and paclitaxel in nanovesicles

EXAFS characterization of oxaliplatin anticancer drug and its degradation in chloride media

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