A validated stability‐indicating gas chromatography method for determination of divalproex sodium impurities in pharmaceutical preparation

Acharya, Subasranjan; Suresh, P.; Srinivasulu, C.; Hemant, Raoutray

doi:10.1002/dta.117

Cited by 5 publications

(4 citation statements)

References 20 publications

(3 reference statements)

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“…Treatment with DC_YM21 after 7 days effectively blocked the proliferation of MV4;11 and KOPN-8 cells, with halfmaximal growth inhibitory concentration (GI 50 ) values of 1.67 ± 0.51 µM and 2.08 ± 0.42 µM, respectively, whereas minimal effect on proliferation was observed in leukemia cells without 72 MLL translocation (Fig. 5b).…”

Section: Growth Inhibition and Cell Cycle Arrest In Leukemia Cellsmentioning

confidence: 94%

“…Before the SHAFTS calculation, diverse conformation generation for each molecule in the database was performed using Discovery Studio 2.5. 72 Subsequently, each conformer was aligned onto the query and the 3D similarity score calculated by SHAFTS; the top-ranked molecules with SHAFTS similarities >1.2 (maximum 2.0) were selected for further validation.…”

Section: Scaffold Hoppingmentioning

confidence: 99%

“…Residues involved in the hydrophobic interactions are shown as starbursts, and hydrogen-bonding interactions are denoted by dotted green lines. Molecular graphics figures were prepared with the LigPlot + program 72.…”

mentioning

confidence: 99%

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Identification of novel small-molecule inhibitors targeting menin–MLL interaction, repurposing the antidiarrheal loperamide

et al. 2016

Org. Biomol. Chem.

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Leukemia with a mixed lineage leukemia (MLL) rearrangement, which harbors a variety of MLL fusion proteins, has a poor prognosis despite the latest improved treatment options. Menin has been reported to be a required cofactor for the leukemogenic activity of MLL fusion proteins. Thus, the disruption of the protein-protein interactions between menin and MLL represents a very promising strategy for curing MLL leukemia. Making use of menin-MLL inhibitors with a shape-based scaffold hopping approach, we have discovered that the antidiarrheal loperamide displays previously unreported mild inhibition for the menin-MLL interaction (IC50 = 69 ± 3 μM). In an effort to repurpose this drug, a series of chemical modification analyses was performed, and three of the loperamide-based analogues, DC_YM21, DC_YM25 and DC_YM26 displayed better activities with IC50 values of 0.83 ± 0.13 μM, 0.69 ± 0.07 μM and 0.66 ± 0.05 μM, respectively. Further treatment with DC_YM21 demonstrated potent and selective blockage of proliferation and induction of both cell cycle arrest and differentiation of leukemia cells harboring MLL translocations, which confirmed the specific mechanism of action. In conclusion, molecules of a novel scaffold targeting menin-MLL interactions were reported and they may serve as new potential therapeutic agents for MLL leukemia.

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Section: Growth Inhibition and Cell Cycle Arrest In Leukemia Cellsmentioning

confidence: 94%

Section: Scaffold Hoppingmentioning

confidence: 99%

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Identification of novel small-molecule inhibitors targeting menin–MLL interaction, repurposing the antidiarrheal loperamide

et al. 2016

Org. Biomol. Chem.

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“…Gas Chromatography -GC). GC metoda opisana je i za određivanje magnezijumove soli valproinske kiseline [4], kao i za određivanje nečistoća dimera natrijum-valproata [5]. LC metoda primenjena je za određivanje valproinske kiseline i njenih soli nakon derivatizacije sa fenacil-bromid -trietilaminom u etanolu [6], dok je LC spregnuta sa Evaporative Light Scattering detektorom (ELSD) primenjena za određivanje 4 antiepileptika (valproinska kiselina, natrijum-valproat, primidon i karbamazepin) u biološkom materijalu [7].…”

Section: Uvodunclassified

Plackett-Burman design in robustness testing of liquid chromatographic method for determination of sodium-valproat

Kojić-Marinković¹,

Tumbas²,

Rakić³

et al. 2014

Arh farmaciju

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U ovom radu opisana je primena Plaket-Burman dizajna u proceni robusnosti metode tečne hromatografije za određivanje sadržaja natrijum-valproata. Kao faktori koji mogu uticati na robusnost metode ispitani su sadržaj acetonitrila, koncentracija natrijum-dihidrogenfosfata, pH vrednost mobilne faze, temperatura kolone, protok mobilne faze i talasna dužina detekcije. U cilju kreiranja plana eksperimenta prema Plaket-Burman dizajnu, na 6 pravih faktora dodato je 5 veštačkih faktora i tako je ispitano 11 faktora izvođenjem 12 eksperimenata. Kao odgovori sistema praćeni su retenciono vreme, broj teorijskih platoa i simetrija pika kao kvalitativni odgovori, dok je kao kvantitativni odgovor praćena površina pika. Na osnovu dobijenih rezultata, a primenom odgovarajućih statističkih i grafičkih metoda, procenjen je uticaj ispitivanih faktora na posmatrane odgovore sistema. Pored toga, za značajne faktore određen je interval pouzdanosti tj. opseg u okviru koga se mogu menjati, a da to ne utiče značajno na odgovor sistema. Na kraju, na osnovu dobijenih rezultata, određeni su i parametri za proveru pogodnosti sistema.

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Choices of chromatographic methods as stability indicating assays for pharmaceutical products: A review

Chew

Khor

Lim

2021

Heliyon

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Stability indicating assay describes a technique which is used to analyse the stability of drug substance or active pharmaceutical ingredient (API) in bulk drug and pharmaceutical products. Stability indicating assay must be properly validated as per ICH guidelines. The important components in a stability indicating assay include sensitivity, specificity, accuracy, reliability, reproducibility and robustness. A validated assay is able to measure the concentration changes of drug substance/API with time and make reliable estimation of the quantity of the degradation impurities. The drug substance is separated and resolved from the impurities. Pros and cons of HPLC, GC, HPTLC, CE and SFC were discussed and reviewed. Stability indicating assay may consist of the combination of chromatographic separation and spectroscopic detection techniques. Hyphenated system could demonstrate parallel quantitative and qualitative analysis of drug substances and impurities. Examples are HPLC-DAD, HPLC-FL, GC-MS, LC-MS and LC-NMR. The analytes in the samples are separated in the chromatography while the impurities are chemically characterised by the spectroscopy in the system. In this review, various chromatographic methods which had been employed as stability indicating assays for drug substance and pharmaceutical formulation were systematically reviewed, and the application of hyphenated techniques in impurities characterisation and identification were also discussed with supporting literatures.

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A validated stability‐indicating gas chromatography method for determination of divalproex sodium impurities in pharmaceutical preparation

Cited by 5 publications

References 20 publications

Identification of novel small-molecule inhibitors targeting menin–MLL interaction, repurposing the antidiarrheal loperamide

Identification of novel small-molecule inhibitors targeting menin–MLL interaction, repurposing the antidiarrheal loperamide

Plackett-Burman design in robustness testing of liquid chromatographic method for determination of sodium-valproat

Choices of chromatographic methods as stability indicating assays for pharmaceutical products: A review

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