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Abstract

A Liquid Chromatography with Tandem Mass Spectrometry Bio-Analytical Method Development and Validation for the Quantification of Zanamivir in Biological Matrices

Author(s): A. S. Mohammad* and Jayanthi Bangaru
Department of Pharmaceutical Analysis and Quality Assurance, Nizam Institute of Pharmacy, Telangana 500004, Hyderabad, 1Department of Pharmacy, Annamalai University, Chidambaram, Tamil Nadu 608002, India

Correspondence Address:
A. S. Mohammad, Department of Pharmaceutical Analysis and Quality Assurance, Nizam Institute of Pharmacy, Telangana 500004, Hyderabad, India, E-mail: [email protected]


Zanamivir is an antiviral agent useful in the treatment and prevention of type A and B kind of influenza viruses in pediatric and adult patients. A specific and accurate analytical method by liquid chromatography with tandem mass spectrometry was developed and validated for the estimation of zanamivir in biological matrices of humans. Ledipasvir was utilized as an internal standard. Chromatographic elution of zanamivir and ledipasvir were attained on C18 Thermo base deactivated silica Hypersil column (50 mm×4.6 mm, 5 μm) with mobile phase of same polarity, made up of 0.1 % formic acid and acetonitrile (35:65, v/v) processed at 0.7 ml/min flow rate. The method was linear over the range of 2.15-64.5 ng/ml with more than 0.999 r2 values, consisting of 2.15 ng/ml as lower limit of quantification. Analytes were subjected for pretreatment by solid-phase extraction procedure with average extraction recovery findings within 95.7±1.23 %. Method accuracy findings were present in between 96.49 % to 103.88 % and the assessed percentage relative standard deviation findings for within and between run precision were ≤6.81 %. Analytes were subjected for variable storage conditions for the assessment of stability and were stable at respective conditions. The developed liquid chromatography with tandem mass spectrometry technique for the quantitation of zanamivir in biological matrix was suitable for routine analysis of patient’s blood samples for the pharmacokinetic studies and drug monitoring.

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