Concept of ecologically acceptable chromatographic methods: Case study on the separation of dronedarone hydrochloride and its degradation products
266 Koncept ekološki prihvatljivih hromatografskih metoda: Studija slučaja na primeru razdvajanja dronedaron hidrohlorida i njegovih degradacionih proizvoda
Аутори
Đajić, NevenaKrmar, Jovana
Stojanović, Jevrem
Svrkota, Bojana
Otašević, Biljana
Malenović, Anđelija
Protić, Ana
Чланак у часопису (Објављена верзија)
Метаподаци
Приказ свих података о документуАпстракт
Recently, concern about the environmental impact of drug analysis methods has increased
significantly. Reversed-phase high-performance liquid chromatography (RP-HPLC), the
predominant technique in drug analysis, relies heavily on organic solvents such as acetonitrile,
which is known for its chromatographic efficiency, but also for its toxicity and flammability. To
address these concerns, it is essential to minimize the use of toxic organic solvents. The aim of
this study is to explore greener RP-HPLC modifications and evaluate their applicability in the
pharmaceutical industry. Methods were developed for the separation of dronedarone
hydrochloride and its degradation products based on experimental design, including micellar
liquid chromatography (MLC), β-cyclodextrin (CD) modified RP-HPLC and ultra-high
performance liquid chromatography (UHPLC). The eco-friendliness of these methods was
assessed using the analytical eco-scale score, green analytical procedure index (GAPI) and...
analytical greenness (AGREE). AGREE appears to be the most suitable, as it revealed the greatest
differences between the compared methods, as well as insights into critical aspects of the methods.
UHPLC and β-CD modified RP-HPLC have been shown to be superior to MLC, and both
methods can be a good choice, depending on whether the ease of implementation or energy
efficiency is considered to be a more important criterion.
U poslednje vreme, zabrinutost za negativan uticaj metoda koje se koriste u analitici lekova
na životnu sredinu je u značajnom porastu. Reverzno-fazna tečna hromatografija visokih
performansi (RP-HPLC) kao dominantno korišćena tehnika u velikoj meri se oslanja na primenu
organskih rastvarača, poput acetonitrila, koji je poznat po hromatografskoj efikasnosti, ali i po
toksičnosti i zapaljivosti. Kako bi se ovi problemi rešili i zaštitilo zdravlje ljudi i životna sredina,
neophodno je upotrebu toksičnih organskih rastvarača svesti na minimum. Cilj ovog istraživanja
bio je da preporuči „zelenije“ modifikacije RP-HPLC metoda. Primenom eksperimentalnog
dizajna razvijene su metode za razdvajanje dronedaron-hidrohlorida i njegovih degradacionih
proizvoda, uključujući micelarnu tečnu hromatografiju (MLC), RP-HPLC metodu modifikovanu
β-ciklodekstrinom (CD) i tečnu hromatografiju ultra visokih performansi (UHPLC). Ekološka
prihvatljivost ovih metoda je procenjena korišćenjem analitičke... eko-skale, indeksa zelene
analitičke procedure (GAPI) i pristupa analitičke zelenosti (AGREE). AGREE se izdvojio kao
najpogodniji, jer je pokazao najveće razlike između navedenih metoda, kao i uvid u kritične
aspekte metoda. UHPLC i β-CD modifikovana RP-HPLC metoda su se pokazale superiornim u
odnosu na MLC. Koja metoda će biti metoda izbora zavisi od toga da li se lakoća implementacije
ili energetska efikasnost smatraju važnijim kriterijumom.
Кључне речи:
RP-HPLC / MLC / UHPLC / cyclodextrin modified HPLC / greenness evaluation methods / ciklodekstrinom modifikovana HPLC / procena ekološke prihvatljivostiИзвор:
Arhiv za farmaciju, 2024, 74, 2, 235-266Издавач:
- Savez farmaceutskih udruženja Srbije, Beograd
- Univerzitet u Beogradu - Farmaceutski fakultet, Beograd
Финансирање / пројекти:
- Министарство науке, технолошког развоја и иновација Републике Србије, институционално финансирање - 200161 (Универзитет у Београду, Фармацеутски факултет) (RS-MESTD-inst-2020-200161)
Институција/група
PharmacyTY - JOUR AU - Đajić, Nevena AU - Krmar, Jovana AU - Stojanović, Jevrem AU - Svrkota, Bojana AU - Otašević, Biljana AU - Malenović, Anđelija AU - Protić, Ana PY - 2024 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/5640 AB - Recently, concern about the environmental impact of drug analysis methods has increased significantly. Reversed-phase high-performance liquid chromatography (RP-HPLC), the predominant technique in drug analysis, relies heavily on organic solvents such as acetonitrile, which is known for its chromatographic efficiency, but also for its toxicity and flammability. To address these concerns, it is essential to minimize the use of toxic organic solvents. The aim of this study is to explore greener RP-HPLC modifications and evaluate their applicability in the pharmaceutical industry. Methods were developed for the separation of dronedarone hydrochloride and its degradation products based on experimental design, including micellar liquid chromatography (MLC), β-cyclodextrin (CD) modified RP-HPLC and ultra-high performance liquid chromatography (UHPLC). The eco-friendliness of these methods was assessed using the analytical eco-scale score, green analytical procedure index (GAPI) and analytical greenness (AGREE). AGREE appears to be the most suitable, as it revealed the greatest differences between the compared methods, as well as insights into critical aspects of the methods. UHPLC and β-CD modified RP-HPLC have been shown to be superior to MLC, and both methods can be a good choice, depending on whether the ease of implementation or energy efficiency is considered to be a more important criterion. AB - U poslednje vreme, zabrinutost za negativan uticaj metoda koje se koriste u analitici lekova na životnu sredinu je u značajnom porastu. Reverzno-fazna tečna hromatografija visokih performansi (RP-HPLC) kao dominantno korišćena tehnika u velikoj meri se oslanja na primenu organskih rastvarača, poput acetonitrila, koji je poznat po hromatografskoj efikasnosti, ali i po toksičnosti i zapaljivosti. Kako bi se ovi problemi rešili i zaštitilo zdravlje ljudi i životna sredina, neophodno je upotrebu toksičnih organskih rastvarača svesti na minimum. Cilj ovog istraživanja bio je da preporuči „zelenije“ modifikacije RP-HPLC metoda. Primenom eksperimentalnog dizajna razvijene su metode za razdvajanje dronedaron-hidrohlorida i njegovih degradacionih proizvoda, uključujući micelarnu tečnu hromatografiju (MLC), RP-HPLC metodu modifikovanu β-ciklodekstrinom (CD) i tečnu hromatografiju ultra visokih performansi (UHPLC). Ekološka prihvatljivost ovih metoda je procenjena korišćenjem analitičke eko-skale, indeksa zelene analitičke procedure (GAPI) i pristupa analitičke zelenosti (AGREE). AGREE se izdvojio kao najpogodniji, jer je pokazao najveće razlike između navedenih metoda, kao i uvid u kritične aspekte metoda. UHPLC i β-CD modifikovana RP-HPLC metoda su se pokazale superiornim u odnosu na MLC. Koja metoda će biti metoda izbora zavisi od toga da li se lakoća implementacije ili energetska efikasnost smatraju važnijim kriterijumom. PB - Savez farmaceutskih udruženja Srbije, Beograd PB - Univerzitet u Beogradu - Farmaceutski fakultet, Beograd T2 - Arhiv za farmaciju T1 - Concept of ecologically acceptable chromatographic methods: Case study on the separation of dronedarone hydrochloride and its degradation products T1 - 266 Koncept ekološki prihvatljivih hromatografskih metoda: Studija slučaja na primeru razdvajanja dronedaron hidrohlorida i njegovih degradacionih proizvoda VL - 74 IS - 2 SP - 235 EP - 266 DO - 10.5937/arhfarm74-49572 ER -
@article{ author = "Đajić, Nevena and Krmar, Jovana and Stojanović, Jevrem and Svrkota, Bojana and Otašević, Biljana and Malenović, Anđelija and Protić, Ana", year = "2024", abstract = "Recently, concern about the environmental impact of drug analysis methods has increased significantly. Reversed-phase high-performance liquid chromatography (RP-HPLC), the predominant technique in drug analysis, relies heavily on organic solvents such as acetonitrile, which is known for its chromatographic efficiency, but also for its toxicity and flammability. To address these concerns, it is essential to minimize the use of toxic organic solvents. The aim of this study is to explore greener RP-HPLC modifications and evaluate their applicability in the pharmaceutical industry. Methods were developed for the separation of dronedarone hydrochloride and its degradation products based on experimental design, including micellar liquid chromatography (MLC), β-cyclodextrin (CD) modified RP-HPLC and ultra-high performance liquid chromatography (UHPLC). The eco-friendliness of these methods was assessed using the analytical eco-scale score, green analytical procedure index (GAPI) and analytical greenness (AGREE). AGREE appears to be the most suitable, as it revealed the greatest differences between the compared methods, as well as insights into critical aspects of the methods. UHPLC and β-CD modified RP-HPLC have been shown to be superior to MLC, and both methods can be a good choice, depending on whether the ease of implementation or energy efficiency is considered to be a more important criterion., U poslednje vreme, zabrinutost za negativan uticaj metoda koje se koriste u analitici lekova na životnu sredinu je u značajnom porastu. Reverzno-fazna tečna hromatografija visokih performansi (RP-HPLC) kao dominantno korišćena tehnika u velikoj meri se oslanja na primenu organskih rastvarača, poput acetonitrila, koji je poznat po hromatografskoj efikasnosti, ali i po toksičnosti i zapaljivosti. Kako bi se ovi problemi rešili i zaštitilo zdravlje ljudi i životna sredina, neophodno je upotrebu toksičnih organskih rastvarača svesti na minimum. Cilj ovog istraživanja bio je da preporuči „zelenije“ modifikacije RP-HPLC metoda. Primenom eksperimentalnog dizajna razvijene su metode za razdvajanje dronedaron-hidrohlorida i njegovih degradacionih proizvoda, uključujući micelarnu tečnu hromatografiju (MLC), RP-HPLC metodu modifikovanu β-ciklodekstrinom (CD) i tečnu hromatografiju ultra visokih performansi (UHPLC). Ekološka prihvatljivost ovih metoda je procenjena korišćenjem analitičke eko-skale, indeksa zelene analitičke procedure (GAPI) i pristupa analitičke zelenosti (AGREE). AGREE se izdvojio kao najpogodniji, jer je pokazao najveće razlike između navedenih metoda, kao i uvid u kritične aspekte metoda. UHPLC i β-CD modifikovana RP-HPLC metoda su se pokazale superiornim u odnosu na MLC. Koja metoda će biti metoda izbora zavisi od toga da li se lakoća implementacije ili energetska efikasnost smatraju važnijim kriterijumom.", publisher = "Savez farmaceutskih udruženja Srbije, Beograd, Univerzitet u Beogradu - Farmaceutski fakultet, Beograd", journal = "Arhiv za farmaciju", title = "Concept of ecologically acceptable chromatographic methods: Case study on the separation of dronedarone hydrochloride and its degradation products, 266 Koncept ekološki prihvatljivih hromatografskih metoda: Studija slučaja na primeru razdvajanja dronedaron hidrohlorida i njegovih degradacionih proizvoda", volume = "74", number = "2", pages = "235-266", doi = "10.5937/arhfarm74-49572" }
Đajić, N., Krmar, J., Stojanović, J., Svrkota, B., Otašević, B., Malenović, A.,& Protić, A.. (2024). Concept of ecologically acceptable chromatographic methods: Case study on the separation of dronedarone hydrochloride and its degradation products. in Arhiv za farmaciju Savez farmaceutskih udruženja Srbije, Beograd., 74(2), 235-266. https://doi.org/10.5937/arhfarm74-49572
Đajić N, Krmar J, Stojanović J, Svrkota B, Otašević B, Malenović A, Protić A. Concept of ecologically acceptable chromatographic methods: Case study on the separation of dronedarone hydrochloride and its degradation products. in Arhiv za farmaciju. 2024;74(2):235-266. doi:10.5937/arhfarm74-49572 .
Đajić, Nevena, Krmar, Jovana, Stojanović, Jevrem, Svrkota, Bojana, Otašević, Biljana, Malenović, Anđelija, Protić, Ana, "Concept of ecologically acceptable chromatographic methods: Case study on the separation of dronedarone hydrochloride and its degradation products" in Arhiv za farmaciju, 74, no. 2 (2024):235-266, https://doi.org/10.5937/arhfarm74-49572 . .