Determination of Nitazoxanide in Biological Matrices by LC-MS/MS Technique: Method Development and Validation
Indian Journal of Pharmaceutical Education and Research
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 C 18 -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
... /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 r 2 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.