Multiple responses optimization in the development of a headspace gas chromatography method for the determination of residual solvents in pharmaceuticals

Teglia, Carla M.; Montemurro, Milagros; Zan, María Mercedes de; Cámara, Marı́a S.

doi:10.1016/j.jpha.2015.02.004

Cited by 24 publications

(9 citation statements)

References 21 publications

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“…The retention of polar solvents on a DB-624 column is relatively stronger at high temperatures and could provide high separation between solvents which has minor differences in boiling points. Since the objective was to develop an efficient HSGC method, a DB-624 column (30 m × 0.53 mm, 3.0 µm film thickness) was selected, which is commonly used for residual solvent determination [26][27][28][29]. As shown in Fig.…”

Section: Selection Of Columnmentioning

confidence: 99%

Development and validation of residual solvent determination by headspace gas chromatography in Imatinib Mesylate API

et al. 2019

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An accurate, precise, robust and sensitive method was developed for residual solvents determination by fast static headspace gas chromatography (HSGC) with flame ionization detector in Imatinib Mesylate API. Residual solvents in drug substances are quantified using gas chromatography with headspace. As per regulatory guidelines, residual solvents must be controlled for release any batches of active pharmaceutical ingredients (API). This paper includes the development and validation of HSGC method for the determination of residual solvents specifically methanol, acetone, dichloromethane, n-hexane, ethyl acetate and pyridine in Imatinib Mesylate API. Imatinib Mesylate is a specific inhibitor of BCR-ABL tyrosine kinase. DB-624 capillary column, 30 m long × 0.53 mm internal diameter, the 3 µm film thickness was used for analysis. To minimize degradation, injector temperature was set at 170 °C. The initial oven temperature was kept at 35 °C for 2 min and used ramp 1 at a rate of 4 °C min −1 to temperature of 80 °C hold for 0 min and used ramp 2 at a rate of 40 °C min −1 to a final temperature of 230 °C for 12 min hold time. Nitrogen was selected as a carrier gas. 1-Methyl-2-Pyrrolidinone (NMP) was used as a sample solvent. The method can be readily used to determine defined residual solvents present in a various range of APIs, intermediates, excipients and drug products.

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Section: Selection Of Columnmentioning

confidence: 99%

Development and validation of residual solvent determination by headspace gas chromatography in Imatinib Mesylate API

et al. 2019

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“…Previous work in this area concentrated on BC or BC composites rather than RBC and no relevant study on the issue of residual solvent/ions produced during the process of BC regeneration has been reported. Residual solvents (RS) and residual ions (RI) may represent a potential risk for human health due to their toxicity and their undesirable side effects [23] and they should be removed through some form of effective post-treatment. Hence, for the first time, an attempt was made to detect RS in RBC filaments using gas chromatography-mass spectrometry (GC-MS) and Inductively Coupled Plasma Emission Spectrometry (ICP-MS) was utilizes to measure the amount of RI.…”

Section: Figmentioning

confidence: 99%

“…As residual solvents (RS) and residual ions (RI) may represent a potential risk for human health due to their toxicity and their undesirable side effects [33], an attempt was made to detect residuals, especially lithium ions in the RBC/BC filaments. It has been reported that lithium can either inhibit or stimulate growth of normal [34,35] and cancer cells [36,37] and has dose-dependent effects [38].…”

Section: Detection Of Residual Solventmentioning

confidence: 99%

Fabrication and investigation of a biocompatible microfilament with high mechanical performance based on regenerated bacterial cellulose and bacterial cellulose

Bremner

Wang

et al. 2017

Materials Science and Engineering: C

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A high-strength regenerated bacterial cellulose (RBC)/bacterial cellulose (BC) microfilament of potential use as a biomaterial was successfully prepared via a wet spinning process. The BC not only consists of a 3-D network composed of nanofibers with a diameter of several hundred nanometers but also has a secondary structure consisting of highly oriented nanofibrils with a diameter ranging from a few nanometers to tens of nanometers which explains the reason for the high mechanical strength of BC. Furthermore, a strategy of partially dissolving BC was used and this greatly enhanced the mechanical performance of spun filament and a method called post-treatment was utilized to remove residual solvents from the RBC/BC filaments. A comparison of structure, properties, as well as cytocompatibility between BC nanofibers and RBC/BC microfilaments was achieved using morphology, mechanical properties, X-ray Diffraction (XRD) and an enzymatic hydrolysis assay. The RBC/BC microfilament has a uniform groove structure with a diameter of 50-60μm and XRD indicated that the crystal form was transformed from cellulose Iα to cellulose III and the degree of crystallinity of RBC/BC (33.22%) was much lower than the original BC (60.29%). The enzymatic hydrolysis assay proved that the RBC/BC material was more easily degraded than BC. ICP detection indicated that the residual amount of lithium was 0.07mg/g (w/w) and GC-MS analysis showed the residual amount of DMAc to be 8.51μg/g (w/w) demonstrating that the post-treatment process is necessary and effective for removal of residual materials from the RBC/BC microfilaments. Also, a cell viability assay demonstrated that after post-treatment the RBC/BC filaments had good cytocompatibility.

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“…RSM is a collection of systematic research widely applied in different disciplines, including chemistry, biology, engineering and others. 17 It includes statistical methods to analyse the recorded data of response variables together with designed factors and to carry out optimization after parametric surrogate models are generated. 17 Although the mathematical results of RSM may lack physical significance, they are statistically significant and more precise than manual comparison work in trend description and prediction.…”

Section: Introductionmentioning

confidence: 99%

“…17 It includes statistical methods to analyse the recorded data of response variables together with designed factors and to carry out optimization after parametric surrogate models are generated. 17 Although the mathematical results of RSM may lack physical significance, they are statistically significant and more precise than manual comparison work in trend description and prediction. 18 Moreover, this approach has been found to be effective for obtaining optimal solutions predicted for the whole range of optimal goal settings instead of being chosen from limited experiments.…”

Section: Introductionmentioning

confidence: 99%

Quantitative effects of glass roof system parameters on energy and daylighting performances: A bi-objective optimal design using response surface methodology

Leng

2020

Indoor and Built Environment

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In regions with a hot-summer/cold-winter climate, a balance between energy-saving and better daylighting performance is often required for the design of a glass roof system. This research aims to reduce the total energy demand and to increase the useful daylight illuminance (UDI), by introducing a response-surface-methodology-based bi-objective optimization approach for three glass roof system models (no shading, exterior blinds, interior shades). Surrogate models were generated to quantify the effect of the glazing material and shading parameters. Our findings have revealed that, in hot-summer/cold-winter climate regions like Nanjing, properties of the glazing material could substitute the effect of shading parameters to enhance energy-saving potentials. However, the use of glazing cannot make up for the effect on the daylight performance. Glass roof systems with a low U-value glazing material and small-slat exterior blinds are generally recommended as the balanced solution to lower the energy demand and raise the UDI200–2000. The substitute relations introduced in the surrogate models and optimal solutions have indicated that there are multiple choices to attain a relatively similar goal to produce an energy-efficient building design for construction.

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Multiple responses optimization in the development of a headspace gas chromatography method for the determination of residual solvents in pharmaceuticals

Cited by 24 publications

References 21 publications

Development and validation of residual solvent determination by headspace gas chromatography in Imatinib Mesylate API

Development and validation of residual solvent determination by headspace gas chromatography in Imatinib Mesylate API

Fabrication and investigation of a biocompatible microfilament with high mechanical performance based on regenerated bacterial cellulose and bacterial cellulose

Quantitative effects of glass roof system parameters on energy and daylighting performances: A bi-objective optimal design using response surface methodology

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