Low Level Quantification of Potential Genotoxic Impurity in Omeprazole Drug Substance by UPLC | Abstract

Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry

ISSN: 0975-413X
All submissions of the EM system will be redirected to Online Manuscript Submission System. Authors are requested to submit articles directly to Online Manuscript Submission Systemof respective journal.


Low Level Quantification of Potential Genotoxic Impurity in Omeprazole Drug Substance by UPLC

Author(s): Vinay Kumar Patcha, Susheela Bhai Gajbhiye, Vundavilli Jagadeesh Kumar, Ray UK, Pavan Kumar KSR, Sreenivas N

A new, sensitive and rapid Ultra-Performance Liquid Chromatography (UPLC) method developed and validated for the determination of potential genotoxic impurity namely 2-(Chloromethyl)-4-methoxy-3,5-dimethylpyridine (CMDP) at trace level in omeprazole by applying the concept of Threshold of Toxicological Concern (TTC), a limit of 12.5 ppm was calculated based on the maximum daily dose of omeprazole drug substance. The UPLC method was developed and validated by using Acquity UPLC HSS C18, 1.8 ?¯??­ (100 × 2.1 mm) column with oven temperature maintaining at 40°C. 0.01 M Phosphate buffer pH 2.5 and acetonitrile were chosen as mobile phase A and B in gradient reverse phase mode. Chromatographic parameters i.e., Flow rate: 0.20 ml/min, wave length detection: 205 nm, injection volume: 5 μl and run time: 18 min were applied for this methodology. The proposed method is specific, sensitive, accurate and precise. The established limits of Limit of Detection (LOD) and Limit of Quantification (LOQ) for this impurity are found to be 1.1 ppm and 3.3 ppm respectively. The average recovery obtained was 100.6% at 4 levels in 12 determinations for CMDP in omeprazole drug substance. This method is a good quality control tool for quantitation of CMDP at very low level in omeprazole. The experimental results are discussed in detail in this research paper.


Select your language of interest to view the total content in your interested language

30+ Million Readerbase
SCImago Journal & Country Rank
Google Scholar citation report
Citations : 25868

Der Pharma Chemica received 25868 citations as per Google Scholar report

Der Pharma Chemica peer review process verified at publons
Der Pharma Chemica- Journals on pharmaceutical chemistry