QUANTITATIVE DETERMINATION OF CRIZOTINIB IN HUMAN PLASMA WITH HIGHPERFORMANCE LIQUID CHROMATOGRAPHY AND ULTRAVIOLET DETECTION

  • BABY NALANDA REVU Department of Pharmaceutical Analysis and Quality Assurance, Shri Vishnu College of Pharmacy (Affiliated to Andhra University), Andhra Pradesh, India. http://orcid.org/0000-0002-1562-0101
  • SRINIVASA RAO ATLA Department of Pharmaceutical Analysis and Quality Assurance, Shri Vishnu College of Pharmacy (Affiliated to Andhra University), Andhra Pradesh, India. http://orcid.org/0000-0002-9314-2459
  • GOWRI SANKAR DANNANA Department of Pharmaceutical Analysis and Quality Assurance, College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India.

Abstract

Objective: A rapid, sensitive, selective, and reproducible reversed-phase high-performance liquid chromatographic method has been developed and validated for the determination of crizotinib (CRZ), a tyrosine kinase inhibitor for targeted therapy of anaplastic lymphoma kinase-positive non-small-cell lung cancer.


Methods: The chromatographic separation was carried out in an isocratic mode on an YMC ODS C18 column with a mobile phase consisting of methanol and water containing 0.1% orthophosphoric acid in the ratio of 50:50 v/v at a flow rate of 0.6 ml/min. The run time was maintained for 10 min and detection was monitored at 267 nm. The method involved reproducible liquid-liquid extraction of drug from human plasma using diethyl ether as extracting solvent.


Results: CRZ and internal standard retention times were 6.86 and 7.94 min, respectively. Calibration curves were linear over a concentration range of 20.41–2041.14 ng/ml with correlation coefficient 0.9994. The lower limit of quantification for CRZ in plasma was 20 ng/ml. No endogenous substances were found to interfere with the peaks of drug and internal standard. The intra- and inter-day precision was <9.0% and the accuracy ranged from 97% to 112% over the linear range. All stability studies showed that CRZ in plasma sample was stable.


Conclusion: This method was found to be simple, selective, precise, accurate, and cost-effective. Hence, the method can be successfully applied to analyze the CRZ concentration in plasma samples for pharmacokinetic and bioequivalence studies.

Keywords: Tyrosine kinase inhibitor, Anaplastic lymphoma kinase, Crizotinib, Liquid-extraction, Pharmacokinetics.

Author Biographies

BABY NALANDA REVU, Department of Pharmaceutical Analysis and Quality Assurance, Shri Vishnu College of Pharmacy (Affiliated to Andhra University), Andhra Pradesh, India.

HOD, Department of Pharmaceutical Analysis & Quality Assurance

GOWRI SANKAR DANNANA, Department of Pharmaceutical Analysis and Quality Assurance, College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India.

Principal & HOD, 

Department of Pharmaceutical Analysis and Quality Assurance, College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh.

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NALANDA REVU, B., S. RAO ATLA, and G. S. DANNANA. “QUANTITATIVE DETERMINATION OF CRIZOTINIB IN HUMAN PLASMA WITH HIGHPERFORMANCE LIQUID CHROMATOGRAPHY AND ULTRAVIOLET DETECTION”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 12, no. 2, Jan. 2019, pp. 363-7, https://innovareacademics.in/journals/index.php/ajpcr/article/view/29272.
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