Hydrolytic Degradation Study of  Lansoprazole, Identification, Isolation  and Characterisation of Base  Degradation Product

Satyanarayana, B.; Pottabathini, Vasudev

doi:10.4236/ajac.2015.62013

Cited by 10 publications

(4 citation statements)

References 17 publications

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“…Earlier studies reported that lansoprazole was significantly more stable under basic and neutral hydrolyses than acidic hydrolysis or oxidation. − Therefore, the forced degradation reactions were carried out at distinct incubation times with sampling performed at different time points; for more details refer to Table .…”

Section: Resultsmentioning

confidence: 99%

Automatic Identification of Lansoprazole Degradants under Stress Conditions by LC-HRMS with MassChemSite and WebChembase

Bonciarelli

Desantis

Goracci

et al. 2021

J. Chem. Inf. Model.

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Stress testing is one of the most important parts of the drug development process, helping to foresee stability problems and to identify degradation products. One of the processes involving stress testing is represented by forced degradation studies, which can predict the impact of certain conditions of pH, moisture, heat, or other negative effects due to transportation or packaging issues on drug potency and purity, ensuring patient safety. Regulatory agencies have been working on a standardization of laboratory procedures since the past two decades. One of the results of those years of intensive research is the International Conference on Harmonization (ICH) guidelines, which clearly define which forced degradation studies should be performed on new drugs, which become a routine work in pharmaceutical laboratories. Since used techniques based on high-performance liquid chromatography coupled with high-resolution mass spectrometry have been developed years ago and are now mastered by pharmaceutical scientists, automation of data analysis, and thus data processing, is becoming a hot topic nowadays. In this work, we present MassChemSite and WebChembase as a tandem to automatize the routine analysis studies without missing information quality, using as a case study the degradation of lansoprazole under acidic, oxidative, basic, and neutral stress conditions.

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Section: Resultsmentioning

confidence: 99%

Automatic Identification of Lansoprazole Degradants under Stress Conditions by LC-HRMS with MassChemSite and WebChembase

Bonciarelli

Desantis

Goracci

et al. 2021

J. Chem. Inf. Model.

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“…6b. Battu and Pottabathini reported a new impurity, 7-(3-methyl-4-(2,2,2-trifluoroethoxy) pyridin-2-yl)-7H-benzo [4,5]imidazo [2,1b]benzo [4,5] imidazo [2,1-d]- [1,3,5]thiadiazine formed in harsh basic conditions [28] . DP-3(L), DP-4(A), DP-6(L) and DP-8(L), were formed in basic hydrolysis.…”

Section: Resultsmentioning

confidence: 99%

Uncovering interaction by QbD in Optimization of Stability-indicating HPLC Method for Simultaneous Estimation of Low Dose Aspirin and Lansoprazole

Fanse¹,

Baghel²,

Rajput³

2016

pharmaceutical-sciences

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Fanse, et al.: Stability-indicating HPLC Method for Aspirin and LansoprazoleIn the present study a quality by design acquiescent method utilizing design of experiment and method operable design regions methodology was evaluated for optimization of chromatographic condition for separation of ten degradation products along with peaks of aspirin and lansoprazole. Box-Behnken design was exploited to evaluate the main and interaction effects of the selected critical process parameters on the critical quality attributes, viz resolution between the peak pairs and retention time of last eluting peak. The optimal separation was predicted at pH 3.6, with a gradient starting at 20% of acetonitrile and initial hold time of 10 min. The results of experimental methods show excellent agreement with predicted results, highlighting the importance of design of experiments in method optimization. The selected working condition was then fully validated according to International Conference on Harmonisation guidelines for linearity, range, accuracy, precision and robustness.

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“…LPZ was reported to degrade rapidly within 6-8 h in basic conditions, especially at high temperature (e.g. 60°C (Battu and Pottabathini, 2015) or 80°C (Shankar et al, 2017)). In this study, LPZ was incorporated in CD-MOFs at lower temperature (50°C) and during a 6 h procedure, in the presence of KOH (200 mM).…”

Section: Synthesis and Characterization Of Lpz Loaded Cd-mofsmentioning

confidence: 99%

“…1, upper panel). Moreover, LPZ is a fragile molecule which readily degrades in both acidic (DellaGreca et al, 2006;Ekpe and Jacobsen, 1999;Gupta et al, 2007) and basic conditions (Battu and Pottabathini, 2015;DellaGreca et al, 2006;Liu et al, 2005), even during storage at 4°C (DiGiacinto et al, 2000). It was interesting to study here whether the integrity of the drug was preserved upon incorporation in CD-MOFs and long-term storage.…”

Section: Introductionmentioning

confidence: 97%

Efficient incorporation and protection of lansoprazole in cyclodextrin metal-organic frameworks

Porcino

Martineau‐Corcos

et al. 2020

International Journal of Pharmaceutics

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HAL is a multidisciplinary open access archive for the deposit and dissemination of scientific research documents, whether they are published or not. The documents may come from teaching and research institutions in France or abroad, or from public or private research centers. L'archive ouverte pluridisciplinaire HAL, est destinée au dépôt et à la diffusion de documents scientifiques de niveau recherche, publiés ou non, émanant des établissements d'enseignement et de recherche français ou étrangers, des laboratoires publics ou privés.

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Hydrolytic Degradation Study of Lansoprazole, Identification, Isolation and Characterisation of Base Degradation Product

Cited by 10 publications

References 17 publications

Automatic Identification of Lansoprazole Degradants under Stress Conditions by LC-HRMS with MassChemSite and WebChembase

Automatic Identification of Lansoprazole Degradants under Stress Conditions by LC-HRMS with MassChemSite and WebChembase

Uncovering interaction by QbD in Optimization of Stability-indicating HPLC Method for Simultaneous Estimation of Low Dose Aspirin and Lansoprazole

Efficient incorporation and protection of lansoprazole in cyclodextrin metal-organic frameworks

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