Identification of Oxidative Degradation Products of Lansoprazole by Using High Resolution Mass Spectrometry Spectral Data - International Journal of Analytical Mass Spectrometry and Chromatography

IJAMSC > Vol.5 No.3, September 2017

Identification of Oxidative Degradation Products of Lansoprazole by Using High Resolution Mass Spectrometry Spectral Data ()

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DOI: 10.4236/ijamsc.2017.53004 1,393 Downloads 3,148 Views Citations

Author(s)

Dev Kant Shandilya¹, Rekha Israni¹, Peter Edward Joseph², Anoop Kumar³, Manoj Pillai³

Affiliation(s)

¹Department of Research, Bhagwant University, Ajmer, India.
²Department of Chemistry, ST. Johns College, Agra, India.
³Sciex, Gurgaon, India.

ABSTRACT

The study focused on the application of high-resolution mass spectrometry for the identification of impurities in pharmaceutical small molecules. A high-performance liquid chromatography (HPLC) coupled high resolution mass spectrometer (HRMS) was used for identification of oxidative degradation impurities (DIs) of lansoprazole. The utilization of HRMS facilitates to determine the accurate mass of impurities and their fragment/product ions. A fast mass spectrometer (MS) compatible reverse phase chromatography method was used to investigate the oxidative stressed impurities. HPLC column; C18 (50 × 4.6 mm, 3.5 μm) was used with gradient elution. Spectral data acquired using information dependent acquisition (IDA) with real time dynamic background subtraction algorithm (DBS). Three oxidative impurities: DI-I (m/z 386.0781), DI-II (m/z 402.0734) and DI-III (m/z 386.0785), was observed during this study; interpretation of high resolution spectral data of all three impurities was carried out; elemental composition and molecular structure was proposed for major fragments. In this study mass error was found ≤7.7 parts per million (ppm).

KEYWORDS

Lansoprazole, Oxidative Degradation Products of Lansoprazole

Share and Cite:

Shandilya, D. , Israni, R. , Joseph, P. , Kumar, A. and Pillai, M. (2017) Identification of Oxidative Degradation Products of Lansoprazole by Using High Resolution Mass Spectrometry Spectral Data. International Journal of Analytical Mass Spectrometry and Chromatography, 5, 57-69. doi: 10.4236/ijamsc.2017.53004.

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