Detection, Isolation and Characterization of Principal Synthetic Route Indicative Impurity in Lansoprazole

Srinivas, Kurella; Mukkanti, K.; Reddy, R. B.; Srinivasulu, Polisetty

doi:10.1155/2010/304315

Cited by 7 publications

(6 citation statements)

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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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“…However, studies reporting the tautomeric populations of benzimidazoles have been overlooked, apparently due to the fast protropic exchange rate on benzimidazole nitrogens at room temperature [26]. Literature studies on benzimidazoles, almost exclusively, focused on synthetic methods and characterisation of benzimidazolyl derivatives [27,28,29]. Only a few researchers have discussed the tautomerism of benzimidazole compounds [24,30], and most studies were aimed at obtaining well-resolved NMR spectra instead of studying the structural tautomerism itself.…”

Section: Anticancer Potentialmentioning

confidence: 99%

Theoretical study of the geometric and electronic characterization of carbendazim-based drug (Nocodazole)

Khattab

2020

Heliyon

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Scarcity in studies defining the precise three-dimensional structure of approved drugs has led to an abandoning of their use for other therapeutic indications. In this manuscript, we solely focus on studying computationally the anticancer drug "Nocodazole" as a model compound for anthelmintic drugs -due to structural similarity-proven to exert anticancer activity such as Mebendazole and Albendazole. Computations on Nocodazole structures deposited in the Protein Data Bank (PDB) revealed possible existence of at least 6 conformers of Nocodazole. By combining the reported experimental UV-Vis data with our calculations, two conformers were assigned as the predominant structures of Nocodazole. In addition, td-DFT calculations revealed that the conformational flexibility of Nocodazole results in significant changes in atomic and molecular charge densities. The results have ramifications in identification of possible conformers of carbendazim-based drugs for repurposing in oncology through giving deep insights in understanding the spatial and electronic changes upon drug binding to anticancer targets.

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“…The system suitability was established by evaluating the system suitability parameters from the chromatograms thus obtained. Typical system suitability parameters include %RSD, Tailing factor (T) and Theoretical plates (N) [12][13][14][15][16][17][18].…”

Section: System Suitabilitymentioning

confidence: 99%

RP-HPLC Method Development and Validation for the Estimation of Lansoprazole in Presence of Related Substances by QbD Approach

Gholve¹,

Sangshetti²,

Bhusnure³

et al. 2021

JPRI

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A rapid specific RP-HPLC method has been developed for the determination of Lansoprazole impurities in the drug substance. The control of pharmaceutical impurities is currently a critical issue in the pharmaceutical industry. The International Council for Harmonization (ICH) has formulated a workable guideline regarding the control of impurities. The objective of the recent study was to develop and validate a HPLC method for the quantitative determination of process-related impurities of Lansoprazole in pharmaceutical drug substance. Lansoprazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl] methyl]-sulfinyl]- 1H-benzimidazole is an proton pump inhibitor used in the management of gastric ulcers. Chromatographic identification of the impurities was carried out by response surface methodology, applying a three-level Box Behnken design with three center points. Three factors selected were a mobile phase, flow rate, column temperature. Evaluation of the main factor, their interaction, and the quadric effect on peak resolution were done on Waters Symmetry C8, 250 x 4.6mm, 5µm column is used for the development of the method. The mobile phase consists of buffer and acetonitrile. The flow rate of the mobile phase was 1.0 ml/min with gradient elution. The column temperature is ambient and the detection wavelength is 235 nm. The injection volume was 10 µL. The method was validated as per ICH guidelines for linearity in the range of 50-150 µg/ml and the LOD & LOQ values obtained were 0.437×10-4 and 0.1325×10-3 µg/ml respectively which specifies the method's sensitivity. The proposed method was successfully used to determine the Lansoprazole impurities in drug substances.

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Detection, Isolation and Characterization of Principal Synthetic Route Indicative Impurity in Lansoprazole

Cited by 7 publications

References 0 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

Theoretical study of the geometric and electronic characterization of carbendazim-based drug (Nocodazole)

RP-HPLC Method Development and Validation for the Estimation of Lansoprazole in Presence of Related Substances by QbD Approach

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