Overcoming the Charged Ion Competition in Triple Quad Chemical Ionization Ion Source for Estimation of Celecoxib in Biological Matrix and its Application to Bioequivalence Study

Naveen Kr Dubey; Kashif Ul Haq; Bharat I. Fozdar

doi:10.1055/a-0983-1303

Drug Research, Table of Contents

Drug Res (Stuttg) 2019; 69(11): 621-629
DOI: 10.1055/a-0983-1303

Original Article

Overcoming the Charged Ion Competition in Triple Quad Chemical Ionization Ion Source for Estimation of Celecoxib in Biological Matrix and its Application to Bioequivalence Study

Authors

Naveen Kr Dubey

¹Jubilant Generics Limited, Noida, India
Kashif Ul Haq

¹Jubilant Generics Limited, Noida, India
Bharat I. Fozdar

²Indira Gandhi National Open University, New Delhi, India

Abstract

The purpose of the study was to develop and validate a sensitive, selective and reproducible method for the estimation of Celecoxib in human plasma. During the development, ion competition phenomenon observed in electrospray ionization ion source of liquid chromatography mass spectrometer system and in order to overcome it, different approaches applied. The Celecoxib and Celecoxib D7 in plasma were extracted by liquid-liquid extraction and separated in less than 4.0 min on a reverse phase C₁₈ column, using isocratic elution with a binary mobile phase in the ratio of 70:30 v/v (Acetonitrile: 0.1% Ammonia Solution). Mass spectrometer was used as detector to quantitate the analytes in positive ion mode, using Atmospheric Pressure Chemical Ionization mode. Since the method was developed to perform the pharmacokinetic end point study for United States and Europe market, the method was fully validated, complying Food and Drug Administration, European Medicines Agency guideline and recommendations of American Association of Pharmaceutical Scientists white papers.

Key words

charge competition - celecoxib - human plasma - bioequivalence - pharmacokinetic study

Full Text

References

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