Recent Advances in Stability Studies of Carbapenems

Cielecka‐Piontek, Judyta; Michalska, Katarzyna; Zalewski, Przemysław; Jelińska, Anna

doi:10.2174/157341211797457989

Cited by 41 publications

(30 citation statements)

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“…As the carbapenems are very susceptible to degradation, selectivity is an important validation parameter. The kind of degradation products of doripenem and biapenem depended on the chemical structures at the C3 substituent and on the affecting factors [23]. It was proved that the HPLC-UV method was selective for the determination of carbapenems in the presence of various degradation products.…”

Section: Discussionmentioning

confidence: 99%

Development and validation of a stability-indicating LC-UV method for the determination of doripenem and biapenem in pharmaceutical dosage forms

Cielecka‐Piontek

Krause²,

Zalewski

et al. 2012

Acta Chromatographica

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Summary.A stability-indicating LC assay method was developed and validated for the quantitative determination of doripenem and biapenem in pharmaceutical dosage forms in the presence of degradation products formed during forced degradation studies. An isocratic RP-HPLC method was developed with a C-18 (250 mm × 4.6 mm, 5 µm) column and 12 mM ammonium acetate-acetonitrile (96:4 v/v) as mobile phase. The flow rate of the mobile phase was 1.0 mL min −1 for doripenem and biapenem. The determination was carried out at the wavelength of 295 nm. The carbapenems were subjected to stress conditions of degradation in aqueous solutions including hydrolysis, oxidation, photolysis, and thermal degradation. The developed method was validated with respect to linearity, accuracy, precision, selectivity, and robustness.

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Section: Discussionmentioning

confidence: 99%

Development and validation of a stability-indicating LC-UV method for the determination of doripenem and biapenem in pharmaceutical dosage forms

Cielecka‐Piontek

Krause²,

Zalewski

et al. 2012

Acta Chromatographica

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“…For example, against members of the family Enterobacteriaceae, Homophiles influenza and Mirabella catarrhal is, the MIC90 (MIC: minimum inhibitory concentration) range from 0.032-0.5 µg mL −1 (Tsuji et al, 1998). In all carbapenems, a β-lactic ring is required for their antibacterial activity (Cielecka-Piontek et al, 2011). Two other parenteral carbapenems panipenem and biapenem are licensed in the Far East, whereas faropenem, an oral penem, is available in Japan and India and the first oral carbapenem, tebipenem received approval in Japan in 2009 (Hikida et al, 1999).…”

Section: Doripenem (S-4661mentioning

confidence: 99%

“…Ninhydrin reagent is most commonly used to identify primary aliphatic amines (Cielecka-Piontek et al, 2011;Psathas et al, 2008). Generally, the main step of this reaction is heating the reagents for a short time in an organic solvent/water mixture; then the absorbance of the reaction product is measured at 580 nm (Gorog, 1995).…”

Section: Reaction With Ninhydrin (Nin)mentioning

confidence: 99%

Utilization of Charge Transfer and Kinetic Methods for the Determination of Doripenem

Al-Shaalan¹

2012

American Journal of Applied Sciences

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Problem statement:This study presents rapid, uncomplicated and sensitive spectrophotometric techniques for the analysis of doripenem in both its pure and pharmaceutical forms. Approach: The main principle of the approaches and procedures that have been developed is the reaction of doripenem as an n-electron donor to ninhydrin and π-acceptors, such as tetracyanoethylene, 7,7,8,8-tetracyanoquinodimethane, 2,3,5,6-tetrachloro-1,4-benzoquinone, 2,3-dichloro-5,6-dicyano-1,4-benzoquinone and chloranilic acid. The wavelengths 580, 264, 320, 357, 375 and 465 nm was used for measuring the resulting complexes for ninhydrin, chlorine, chloranilic acid, DDQ, TCNQ and TCNE respectively. Results: The suggested procedures for the determination of doripenem were successfully put into practice with good recovery; the percent recovery ranged from 99.31-100.55. Benes-Hildebrand plots were also used to study the association constants and the free energy changes. Conclusion: The results of the CT method agree with those of the kinetic method and there is no significant difference between them.

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“…The considerable susceptibility to degradation of tebipenem, which negatively affects the antibacterial activity of the drug, is associated with the presence of 4:5 bicyclic fused rings (Figure 1) 3 . Studies into the stability of antibiotics have reported formation of various degradation products and changes in the kinetics of degradation depending on the action of physicochemical factors [4][5][6][7] . Kinetic and thermodynamic analysis of degradation in solutions and in the solid state has been conducted for cabapenems registered for medicinal use [8][9][10][11] .…”

Section: Introductionmentioning

confidence: 99%

Solid-state stability studies of crystal form of tebipenem

Talaczyńska

Lewandowska

Garbacki

et al. 2015

Drug Development and Industrial Pharmacy

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The aim of this study was to determine the kinetic and thermodynamic parameters of tebipenem degradation in the solid state. The process was analyzed based on the results obtained by a high performance liquid chromatography (HPLC) method using ultraviolet diode-array detector (DAD)/electrospray ionization tandem mass spectrometry (Q-TOF-MS/MS), Fourier transform infrared spectroscopy (FT-IR) and Raman spectroscopic (RS) studies. In dry air, the degradation of tebipenem was a first-order reaction depending on the substrate concentration while at an increased relative air humidity tebipenem was degraded according to the kinetic model of autocatalysis. The thermodynamic parameters: energy of activation (Ea), enthalpy (ΔH(≠a)) and entropy (ΔS(≠a)) of tebipenem degradation were calculated. Following a spectroscopic analysis of degraded samples of tebipenem, a cleavage of the β-lactam bond was proposed as the main degradation pathway, next confirmation using HPLC-Q-TOF-MS/MS method.

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Recent Advances in Stability Studies of Carbapenems

Cited by 41 publications

References 0 publications

Development and validation of a stability-indicating LC-UV method for the determination of doripenem and biapenem in pharmaceutical dosage forms

Development and validation of a stability-indicating LC-UV method for the determination of doripenem and biapenem in pharmaceutical dosage forms

Utilization of Charge Transfer and Kinetic Methods for the Determination of Doripenem

Solid-state stability studies of crystal form of tebipenem

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