Recent developments in the determination of residual solvents in pharmaceutical products by microextraction methods

Mirmoghaddam, Majid; Kaykhaii, Massoud; Yahyavi, Hossein

doi:10.1039/c5ay01970b

Cited by 18 publications

(9 citation statements)

References 78 publications

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“…The specific literature on individual methodologies is summarized in Table . Other literature sources describe the determination of pollutants , pesticides , drugs or inorganic compounds . Another group of reviews summarizes the application of microextraction techniques for analysis of various compounds in foodstuffs , in natural products or in water and wine .…”

Section: Sdmementioning

confidence: 99%

Critical evaluation of microextraction pretreatment techniques – Part 1: Single drop and sorbent‐based techniques

Havlíková

Čabala

Pacáková

et al. 2018

J of Separation Science

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Sample pretreatment techniques or preconcentration constitute a very important step before the analysis of environmental, clinical, pharmaceutical, and other complex samples. Thanks to extraction techniques it is possible to achieve higher method sensitivities and selectivities. Miniaturization microextraction methods make them more environmentally friendly and only small amounts of samples are required. In the past 30 years, a number of microextraction methods have been developed and used and are documented in thousands of articles. Many reviews have been written focusing on their use in specified professional fields or on the latest trends. Unfortunately, no uniform nomenclature has been introduced for these methods. Therefore, this review attempts to classify all the essential microextraction techniques and describes their advantages, disadvantages, and the latest innovations. The methods are divided into two main groups: single drop and sorbent‐based techniques according to the type of extraction phase.

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Section: Sdmementioning

confidence: 99%

Critical evaluation of microextraction pretreatment techniques – Part 1: Single drop and sorbent‐based techniques

Havlíková

Čabala

Pacáková

et al. 2018

J of Separation Science

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“…Class 2 solvents are not genotoxic impurities, but with a level of toxicity that must be limited in drug products to the indicated concentration. Class 3 solvents have the lowest risk and are limited to 5000 ppm [1,5].…”

Section: Introductionmentioning

confidence: 99%

“…Several headspace techniques such as static headspace (SHS) [7][8][9][10][11], dynamic headspace [12] and headspace solid phase microextraction [5,13] can be employed. Static headspace analysis is probably the most widely used technique for residual solvent analysis in pharmaceuticals as it is inexpensive, easy to perform and automate, can be successfully used routinely in control labs.…”

Section: Introductionmentioning

confidence: 99%

Headspace gas chromatographic analysis of residual solvents in pharmaceuticals: comparison of two matrix media

Vičkačkaitė¹,

Jevtuch²,

Poškus³

et al. 2020

chemija

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Dimethylformamide (DMF) and a deep eutectic solvent choline chloride-ethylene glycol (ChCl-Eg) were investigated as potential matrix media for static headspace gas chromatographic (SHS-GC) determination of residual solvents in pharmaceuticals. Sample equilibration temperature, equilibration time and injection time were optimized. In the case of DMF 140°C equilibration temperature was applied. For ChCl-Eg equilibration temperature could not exceed 80°C as ChCl-Eg started to degrade at elevated temperatures. The higher equilibration temperature of DMF solutions favoured a transition of the analytes to the headspace and consequently resulted in lower detection limits of the analytes. Thus DMF has been considered a more suitable matrix medium than ChCl-Eg and was applied for the SHS-GC determination of residual solvents in pharmaceuticals.

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“…In addition to requiring a substantial amount of material, the headspace procedure requires between 45 and 60 min for sample equilibration prior to injection. Others have investigated a variety of alternative sampling techniques including purge and trap [2] , direct thermal extraction [3] , [4] , solid-phase microextraction (SPME) [5] , [6] , [7] , and single-drop microextraction (SDME) techniques [8] , [9] for measuring residual solvents in pharmaceutical samples. The purge and trap and direct thermal extraction techniques offer good sensitivity and only need a few milligrams of material, but they require customized apparatus and method optimization for each sample lot.…”

Section: Introductionmentioning

confidence: 99%

Chromatoprobe as a sample-sparing technique for residual solvent analysis of drug discovery candidates by gas chromatography

Poronsky

Cutrone

2017

Journal of Pharmaceutical Analysis

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In drug discovery research, residual solvent measurement is an integral part of purity analysis for synthesis of a drug candidate before it is used for toxicity testing. This is usually carried out using gas chromatography (GC) with direct injection sample introduction. This method requires testing compounds to be soluble at high concentrations (>50 mg/mL, usually in DMSO) to achieve acceptable sensitivity, a hurdle which is not always achievable for some samples such as cyclic peptides and oligonucleotides. To overcome the limitation associated with the direct injection approach, a new method using the Chromatoprobe thermal extraction device was developed for quantifying residual solvents of drug discovery compounds. This method not only consumes significantly less material (less than 1 mg), but also shows higher sensitivity than the direct injection approach. In addition, because no diluent is required with the Chromatoprobe thermal extraction, all residual solvents can be detected and measured without further method optimization. In our study, we compared data from GC residual solvent analysis using the Chromatoprobe solid sample introduction to those of the direct injection method for seven in-house samples. Our results showed a good agreement between the data from these two sample introduction methods. Thus, the Chromatoprobe sample introduction method provided a sample-sparing alternative to the direct injection method for the measurement of residual solvents in drug discovery. This method can be particularly useful for residual solvent analysis in samples that are available only in limited amounts, poorly soluble, and/or unstable in the diluents used for the direct injection method.

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Recent developments in the determination of residual solvents in pharmaceutical products by microextraction methods

Abstract: Recent developments in the determination of residual solvents in pharmaceutical products by microextraction methods.

Cited by 18 publications

References 78 publications

Critical evaluation of microextraction pretreatment techniques – Part 1: Single drop and sorbent‐based techniques

Critical evaluation of microextraction pretreatment techniques – Part 1: Single drop and sorbent‐based techniques

Headspace gas chromatographic analysis of residual solvents in pharmaceuticals: comparison of two matrix media

Chromatoprobe as a sample-sparing technique for residual solvent analysis of drug discovery candidates by gas chromatography

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