Abdul Saleem Mohammad

Determination of nitazoxanide in biological matrices by LC-MS/MS technique: method development and validation - Vol.56(2), Apr-June - Karnataka Association of Pharmaceutical Teachers of India (APTI) 2022 - 539-545p.

Background: Determination of pharmaceuticals in the biological matrices is essential for
toxicologic and pharmacokinetic applications. The main objective of the current work
was to develop a bioanalytical method for quantifying nitazoxanide in biological samples
by LC-MS/MS. Materials and Methods: Chromatographic elution of nitazoxanide and
linagliptin were achieved on C18
-hypersil (5 μ, 50x4.6mm) stationary phase with mobile
phase consisting of acetonitrile and 0.1% HCOOH (75:15, v/v) processed at 0.8 ml/min
flow rate. Linagliptin was utilized as an internal standard (IS). Results: The method
was linear in the concentration levels of 0.53–21.2 ng/ml with more than 0.999
r2
values, consisting of 0.53 ng/ml as the lower limit of quantification (LLOQ). Analytes
were subjected to pretreatment by liquid-liquid extraction (LLE) procedure with average
extraction recovery findings within 99.93±5.04%. Method accuracy findings were
present in between 96.44% to 104.31%, and the assessed percentage relative standard
deviation findings for within and between run precision were ≤ 4.68%. Conclusion: The
developed LC-MS/MS procedure for quantitating nitazoxanide in the biological matrix
was suitable for routine analysis of patients’ blood samples for pharmacokinetic studies
and drug monitoring.


PHARMACEUTICS