scholarly journals Quantification of Cefepime, Meropenem, Piperacillin, and Tazobactam in Human Plasma Using a Sensitive and Robust Liquid Chromatography-Tandem Mass Spectrometry Method, Part 2: Stability Evaluation

2018 ◽  
Vol 62 (9) ◽  
Author(s):  
Ronilda D'Cunha ◽  
Thanh Bach ◽  
Beth Ann Young ◽  
Peizhi Li ◽  
Demet Nalbant ◽  
...  

ABSTRACT Although the stability of β-lactam antibiotics is a known issue, none of the previously reported bioanalytical methods had an adequate evaluation of the stability of these drugs. In the current study, the stability of cefepime, meropenem, piperacillin, and tazobactam under various conditions was comprehensively evaluated. The evaluated parameters included stock solution stability, short-term stability, long-term stability, freeze-thaw stability, processed sample stability, and whole-blood stability. When stored at −20°C, the stock solution of meropenem in methanol was stable for up to 3 weeks, and the stock solutions of cefepime, piperacillin, and tazobactam were stable for up to 6 weeks. All four antibiotics were stable in human plasma for up to 3 months when stored at −80°C and were stable in whole blood for up to 4 h at room temperature. Short-term stability results indicated that all four β-lactams were stable at room temperature for 2 h, but substantial degradation was observed when the plasma samples were stored at room temperature for 24 h, with the degradation rates for cefepime, meropenem, piperacillin, and tazobactam being 30.1%, 75.6%, 49.0%, and 37.7%, respectively. Because the stability information is method independent, our stability results can be used as a reference by other research groups that work with these antibiotics.

2020 ◽  
Vol 58 (5) ◽  
pp. 753-757 ◽  
Author(s):  
Elisa Danese ◽  
Martina Montagnana ◽  
Claudio Brentegani ◽  
Giuseppe Lippi

AbstractBackgroundAnalysis of plasma metanephrine (MN) and normetanephrine (NMN) with liquid chromatography tandem mass spectrometry (LC-MS/MS) is the gold standard for the screening of pheochromocytomas and paragangliomas (PPGLs). As scarce information is available on the stability of MNs in diagnostic samples, this study was aimed at analyzing the short-term stability of plasma free MNs in whole blood and plasma, using LC-MS/MS.MethodsThe stability of plasma MNs was evaluated after sample collection at 1, 2 and 3 h in whole blood, and at 2, 4 and 6 h in centrifuged samples. Both studies were performed while maintaining the samples at room temperature (RT) and at 4 °C. The ClinMass Complete Kit (Recipe, Munchen, Germany) was used for measuring MNs with LC-MS/MS (Nexera X2 UHPLC-4500MD Sciex). Differences from the baseline (T0) were assessed using repeated measures one-way ANOVA, Students’ paired t-test and a comparison of the mean percentage changes with the total change limit (TCL).ResultsStatistically significant differences from T0 were found for both MNs (p < 0.001) in whole blood stored at RT, and for NMN (p = 0.028) but not MN (p = 0.220) at 4 °C. The mean difference exceeded the TCL after 1 h and 3 h at RT for MN, and after 1 h at RT for NMN. Statistically significant differences from T0 were only observed in the plasma samples for NMN at RT (p = 0.012), but the variation was within the TCL.ConclusionsMN and NMN displayed different patterns of stability before and after centrifugation. Even short-time storage at RT in whole blood should hence be avoided.


2006 ◽  
Vol 41 (5) ◽  
pp. 437-441 ◽  
Author(s):  
Lisa A. Boothby ◽  
Rajanikanth Madabushi ◽  
Vipul Kumar ◽  
Burnis D. Breland ◽  
Randy C. Hatton ◽  
...  

Purpose Since IV admixtures of oxytocin in the final working concentrations are not commercially available, oxytocin admixtures must be prepared immediately before use or compounded in a sterile laminar flow hood and stored until needed. Although published reports indicate short-term stability of oxytocin in Ringer's lactate solution and Ringer's lactate-dextrose 5%, longer-term stability data at various temperatures are lacking. Methods A stability assay was developed, validated, and executed with oxytocin at two different concentrations in Ringer's lactate solution. Stability was assessed at 4 and 25°C over 31 days. Results This study shows that commonly used dilutions of oxytocin in Ringer's lactate solution retain greater than 90% of initial concentrations, when stored at room temperature or refrigerated for 31 days. These data show that oxytocin admixed with Ringer's lactate solution has extended chemical stability after preparation. Conclusions Demonstration of extended stability of oxytocin in Ringer's lactate solution will allow hospitals to give longer dating to oxytocin IV admixtures, provided they are prepared in a sterile environment and monitored in compliance with USP <797> guidelines. This should help minimize the potentially dangerous practice of admixing this IV solution at the bedside.


1960 ◽  
Vol 04 (03) ◽  
pp. 376-388 ◽  
Author(s):  
J Dieter Geratz ◽  
John B. Graham

Summary1. PTC activity was assayed in 26 units of human plasma prepared from whole blood stored for 3 weeks at 4° C. The plasma had been frozen and stored at — 20° C for additional periods ranging from a few days to 4 months. High PTC activity was still present in the plasma at the end of this period, the activity averaging 95% of normal.2. The PTC activity of 19 samples of “reclaimed“ plasma stored for an additional 6 months at — 20° C decreased by an average of 23%. This decrease was statistically significant.3. Liquid plasma kept at room temperature for 5½—7½ months contained no PTC activity.4. Lyophilized plasma stored at room temperature for 6—8 years contained an average of 30% PTC activity. Lyophilized plasma stored at — 20° C for 4 years contained 68% PTC activity.5. ACD and disodium hydrogen citrate anticoagulant solutions served equally well in preserving PTC activity in whole blood stored in glass tubes over a period of 3 weeks at 4° C.6. “Reclaimed“ plasma from outdated bank blood provided effective hemostasis in two operations for the removal of 20 teeth from a severely PTC-deficient patient.7. The high PTC activity of “reclaimed“ plasma was confirmed by the close agreement between the PTC level expected in a PTC deficient patient after transfusion of such plasma and that observed.


1987 ◽  
Vol 33 (12) ◽  
pp. 2299-2300 ◽  
Author(s):  
R F Murphy ◽  
F M Balis ◽  
D G Poplack

Abstract We studied the stability of 5-fluorouracil (5-FU) in plasma and whole blood kept at room temperature and on ice for 1 to 24 h. At room temperature, there was a steady loss of 94% of the parent drug over 24 h in whole blood and 52% in plasma. In the presence of an excess of uracil, 5-FU was stable for 24 h, suggesting that the loss of 5-FU is the result of enzymatic degradation. 5-FU is more stable in whole blood and plasma when samples are kept cold. For blood and plasma samples maintained on ice, the loss was only 30% and 10% of the parent drug in the respective samples over 24 h. Frozen plasma samples (-20 degrees C) were stable for five weeks. Blood specimens collected for quantifying 5-FU should be immediately placed on ice, and the plasma should be separated and frozen as promptly as possible.


1995 ◽  
Vol 377 ◽  
Author(s):  
Mohan K. Bhan

ABSTRACTWe have systematically investigated the effects of addition of sub-ppm levels of boron on the stability of a-Si:H films and p-i-n devices, deposited by PE-CVD technique. The films thus produced with appropriate amounts of boron, show a significant improvement in stability, when soaked under both AM 1.5 (short-term) as well as 10×sun (long-term) illumination conditions. The opto-electronic properties of the films are quite respectable It is concluded that boron compensates the native impurities by forming donor-acceptor pairs, which reduces the “fast” defects and hence the initial degradation of the films. It is also speculated that boron may also be improving the short-term stability, by reducing the recombination of light generated electrons and holes, by converting D° into D+ states. The long-term stability appears to get affected by hydrogen dilution which seems to reduce the amount of “slow” defects. As a result of B doping of i-layer, the initial conversion efficiency of the devices decreases. It is presumed that our devices may contain an enhanced level of boron impurity, than expected, making them as worse material and to degrade less.


1989 ◽  
Vol 35 (12) ◽  
pp. 2313-2316 ◽  
Author(s):  
S E Hankinson ◽  
S J London ◽  
C G Chute ◽  
R L Barbieri ◽  
L Jones ◽  
...  

Abstract We examined the stability of lipids, carotenoids, alpha-tocopherol, and endogenous hormones in plasma prepared from whole blood that had been mailed to a central location for processing. Initially, to simulate transport conditions, whole-blood samples were stored in the laboratory, either at room temperature or cooled, for up to 72 h before processing. In the latter samples, lipid concentrations changed up to 1.4% per day, carotenoids up to -5.5%, and hormones up to 9.5%. In a second study, analyte concentrations in plasma from cooled whole blood mailed via overnight courier were compared with those from plasma that had been immediately separated, frozen, and mailed via overnight courier. Concentrations of cholesterol, high-density lipoprotein subfraction 3, apolipoprotein B, and retinol were stable. Overall, for each marker except estradiol, the between-person variation was at least twice the within-person variation. In a third study, at least 340 micrograms of DNA was recovered from 30 mL of cool-shipped whole blood. Our results indicate that shipping whole-blood samples by overnight courier is feasible for assay of several biochemical markers of interest in epidemiological research.


2013 ◽  
Vol 18 (2) ◽  
pp. 122-127 ◽  
Author(s):  
Jordan T. Morrison ◽  
Ralph A. Lugo ◽  
Jim C. Thigpen ◽  
Stacy D. Brown

OBJECTIVE The purpose of this study was to examine the stability of a generic lansoprazole product in a 3 mg/mL sodium bicarbonate suspension under room temperature and refrigerated conditions. METHODS Lansoprazole suspensions (3 mg/mL) were prepared in triplicate using an 8.4% sodium bicarbonate vehicle for each storage condition (room temperature and refrigerated). During 1 month, samples from each replicate were periodically removed and analyzed for lansoprazole concentration by liquid chromatography–tandem mass spectrometry (LC-MS/MS). Each sample was spiked with 10 mg/L omeprazole to serve as the internal standard. A positive electrospray LC-MS/MS method was validated over the calibration range of 5 to 25 mg/L using Food and Drug Administration Guidance. The identities of the analyte and internal standard in the samples were verified by monitoring the MS/MS transitions of m/z 370 to m/z 252 and m/z 346 to m/z 198 for lansoprazole and omeprazole, respectively. Additionally, the pH of the suspensions was monitored throughout the study. RESULTS The stability of lansoprazole in the oral sodium bicarbonate suspension under refrigeration is compromised prior to what has been previously reported in the literature. Samples kept at room temperature lost &gt;10% of the lansoprazole after 48 hours compared with the refrigerated samples, which maintained integrity up to 7 days. No statistically significant difference was found between the pH of the room temperature and refrigerated suspension samples, indicating that this factor is not the cause for the differences in stability at these two conditions. CONCLUSIONS This study suggests that the extemporaneously compounded lansoprazole oral suspension prepared in 8.4% sodium bicarbonate should not be stored in plastic oral syringes longer than 48 hours at room temperature and no longer than 7 days when refrigerated. These data indicate an expiration time earlier than that previously reported for the refrigerated product (14 days).


Lipids ◽  
2016 ◽  
Vol 51 (2) ◽  
pp. 193-198 ◽  
Author(s):  
Daniele Pupillo ◽  
Manuela Simonato ◽  
Paola E. Cogo ◽  
Alexandre Lapillonne ◽  
Virgilio P. Carnielli

2019 ◽  
Vol 4 (3) ◽  
pp. 410-414
Author(s):  
Olive Tang ◽  
Elizabeth Selvin ◽  
Valerie Arends ◽  
Amy Saenger

2019 ◽  
Vol 55 (3) ◽  
pp. 188-192
Author(s):  
M. L. Colsoul ◽  
A. Breuer ◽  
N. Goderniaux ◽  
J. D. Hecq ◽  
L. Soumoy ◽  
...  

Background and Objective: Infusion containing lorazepam is used by geriatric department to limit anxiety disorders in the elderly. Currently, these infusions are prepared according to demand by the nursing staff, but the preparation in advance in a centralized service could improve quality of preparation and time management. The aim of this study was to investigate the long-term stability of this infusion in polypropylene syringes stored at 5 ± 3°C. Then, results obtained were compared with stability data of lorazepam in syringes stored at room temperature, glass bottles at 5 ± 3°C, and glass bottles at room temperature. Method: Eight syringes and 6 bottles of infusion were prepared by diluting 1 mL lorazepam 4 mg in 23 mL of NaCl 0.9% under aseptic conditions. Five syringes and 3 bottles were stored at 5 ± 3°C and 3 syringes and 3 bottles were stored at room temperature for 30 days. During the storage period, particle appearance or color change were periodically checked by visual and microscope inspection. Turbidity was assessed by measurements of optical density (OD) at 3 wavelengths (350 nm, 410 nm, 550 nm). The stability of pH was also evaluated. The lorazepam concentrations were measured at each time point by high-performance liquid chromatography with ultraviolet detector at 220 nm. Results: Solutions were physically unstable in syringes at 5 ± 3°C after 4 days: crystals and a drop of OD at 350 nm were observed. However, pH was stable. After 2 days, solutions were considered as chemically unstable because a loss of lorazepam concentration higher than 10% was noticed: the lower 1-sided confidence limit at 95% was below 90% of the initial concentration. To assess temperature and polypropylene influence, results were compared with those obtained for syringes at room temperature and bottles at 5 ± 3°C and room temperature. Precipitation, drop of OD at 350 nm, and chemical instability were observed in all conditions. Conclusion: Solutions of lorazepam were unstable after 2 days in syringes at 5 ± 3°C. Preparation in advance appears, therefore, not possible for the clinical use. Storage conditions (temperature and form) do not improve the stability.


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