A novel, reversed-phase ultra-performance liquid chromatographic method was developed and validated for the determination of the assay and related substances of Lansoprazole (LAN) in bulk drug and capsule dosage forms. The related substances include degradation and process-related impurities. The method was developed using the Waters Acquity BEH C18 column and gradient program with mobile phase A as a pH 7.0 phosphate buffer and methanol in the ratio of 90: 10 (v/v), and mobile phase B as methanol and acetonitrile in the ratio of 50:50 (v/v). Lansoprazole and its impurities were monitored at 285 nm. Lansoprazole was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal, humidity, and photolytic degradation and found to degrade significantly under acid and oxidative stress conditions. The degradation products were well-resolved from the main peak and its impurities, proving the stability-indicating power of the method. The performance of the method was validated according to the present ICH guidelines for specificity, limit of detection, limit of quantification, linearity, accuracy, precision, ruggedness, and robustness.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3617664 | PMC |
| http://dx.doi.org/10.3797/scipharm.1210-09 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Greenness-sustainability metrics for assessment smart-chemometric spectrophotometric strategy for evaluation of the combination of six gastric proton-pump inhibitors with two selected impurities.
MethodsX
June 2024
Chemistry Department, College of Science, University of Sulaimani, Sulaymaniyah, Iraq.
Green analytical approaches are employed for the determination of active pharmaceutical ingredients, in conjunction with their impurities. Smart chemometric spectrophotometric techniques, including orthogonal partial least square (OPLS), variable selection such as genetic algorithm (GA-OPLS), and interval selection (i-OPLS), were utilized. These chemometric models were implemented for assessing six proton-pump inhibitors Omeprazole, Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole, and Dexlansoprazole along with two selected official impurities, namely 4-Desmethoxy omeprazole impurity and Rabeprazole-impurity B.
View Article and Find Full Text PDFDNA adductomics aided rapid screening of genotoxic impurities using nucleosides and 3D bioprinted human liver organoids.
Talanta
June 2024
Department of TCMs Pharmaceuticals, China Pharmaceutical University, Nanjing, 211198, China. Electronic address:
Current genotoxicity assessment methods are mainly employed to verify the genotoxic safety of drugs, but do not allow for rapid screening of specific genotoxic impurities (GTIs). In this study, a new approach for the recognition of GTIs has been proposed. It is to expose the complex samples to an in vitro nucleoside incubation model, and then draw complete DNA adduct profiles to infer the structures of potential genotoxic impurities (PGIs).
View Article and Find Full Text PDFChiral separation of lansoprazole and rabeprazole by capillary electrophoresis using dual cyclodextrin systems.
Electrophoresis
November 2019
Department of Pharmaceutical Chemistry, Semmelweis University, Budapest, Hungary.
Novel capillary electrophoresis methods using CDs as chiral selectors were developed and validated for the chiral separation of lansoprazole and rabeprazole, two proton pump inhibitors. Fourteen different neutral and anionic CDs were screened at pH 4 and 7 in the preliminary analysis. Sulfobutyl-ether-β-CD with a degree of substitution of 6.
View Article and Find Full Text PDFDetermination of S-(-)-lansoprazole in dexlansoprazole preparation by capillary zone electrophoresis.
Arch Pharm Res
August 2017
College of Pharmacy, Kangwon National University, Chuncheon, 24341, South Korea.
Capillary zone electrophoresis was successfully applied to the enantiomeric purity determination of dexlansoprazole using sulfobutyl ether-β-cyclodextrin and methyl-β-cyclodextrin as chiral selectors. Separations were carried out in a 50 μm, 64/56 cm fused-silica capillary. The optimized conditions included 90 mM phosphate buffer, pH 6.
View Article and Find Full Text PDFDoubly charged trimeric cluster ions: effective in mutual chiral recognition of tadalafil and three proton pump inhibitors.
Analyst
February 2017
Institute of Drug Metabolism and Analysis, College of Pharmaceutical Sciences, Hangzhou 310058, Zhejiang, PR China. and Zhejiang Province Key Laboratory of Anti-Cancer Drug Research, Zhejiang University, Hangzhou 310058, Zhejiang, PR China.
Mutual chiral recognition of four stereoisomers of tadalafil and three pairs of enantiomers of proton pump inhibitors (PPIs) including pantoprazole, lansoprazole, and omeprazole, as well as quantitative analysis of enantiomeric excess is achieved on the basis of the competitive fragmentation of doubly charged trimeric Ni cluster ions. Compared with a singly charged trimeric cluster ion, a doubly charged trimeric cluster ion was proved efficient in the recognition of chiral drugs with one or multiple chiral centers, due to its rich fragmentation ions. Upon collision-induced dissociation (CID), the cluster ion [Ni(PPIs)(tadalafil)] yielded two diagnostic ions [tadalafil + H] and [tadalafil - benzo[d][1,3]dixoloe] through electrospray ionization quadrupole time-of-flight mass spectrometry.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!