Determination of Nitazoxanide in Biological Matrices by LC-MS/MS Technique: Method Development and Validation

ABSTRACT

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.

KEYWORDS

• Nitazoxanide
• Antiviral
• LC-MS/MS
• Validation
• Accuracy

Showing references and in-text citations exactly as published.

• DOI10.5530/ijper.56.2.76Copy

RELATED ARTICLES

Matched on section and article type within this issue of IJPER.

• Article · VOLUME 56, ISSUE 2Application of Central Composite Design for Development of Celecoxib Loaded Lipospheres: Formulation and in-vitro CharacterizationMoreshwar Patil, Diksha Sonawane, Sandeep Sonawane, Deepak Bhambere, Sanjay Kshirsagar · pp. 405–413Original ArticleSame type: Article
• Article · VOLUME 56, ISSUE 2Formulation and Evaluation of Bendamustine Loaded Polymeric NanoparticleMallikarjun Telsang, Pradeep D, Wilson B, Vasia Tamreen, Shaik Sadik, Mohammed Habeebuddin, Afzal Haq Asif, Mohammed Basheeruddin Asdaq, Sree Harsha Nagaraja, Syed Dawood Noor · pp. 414–419Original ArticleSame type: Article
• Article · VOLUME 56, ISSUE 2Investigation on in-vitro Dissolution and Tableting Properties Enhancement of Etodolac using Stearoyl polyoxyl-32-glycerides as Novel Solid Melt CarrierPradnya Salunkhe, Prashant B Gurav, Vipul Sansare, Sujit Nagare · pp. 420–428Original ArticleSame type: Article
• Article · VOLUME 56, ISSUE 2Synthesis, Characterization and Comparison of Novel Poly (sebacic anhydride) Biopolymeric Implants and Microspheres for the Controlled Release of an Anticancer DrugShabari Girinath Kala, Santhivardhan Chinni · pp. 429–437Original ArticleSame type: Article