BIOANALYTICAL RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF CLOPIDOGREL BISULFATE IN WISTER RAT PLASMA AND ITS APPLICATION TO PHARMACOKINETIC STUDY

Authors

  • RAMYA SRI SURA Department of Pharmacy, University College of Technology, Osmania University, Hyderabad 500007, Telangana, India
  • SUBRAHMANYAM CVS Gokaraju Rangaraju College of Pharmacy, Osmania University, Hyderabad 500090, Telangana, India
  • SHYAM SUNDER RACHAMALLA Department of Pharmacy, University College of Technology, Osmania University, Hyderabad 500007, Telangana, India

DOI:

https://doi.org/10.22159/ijap.2022v14i1.43328

Keywords:

Keywords: RP-HPLC, Bioanalytical method, clopidogrel bisulfate, Wister rat plasma.

Abstract

Objective: A novel, simple, precise, accurate, sensitive, and reproducible HPLC method for determining clopidogrel bisulfate in Wister rat plasma was developed and validated.

Methods: The chromatographic separation was performed using Xterra C18 (250 x 4.6 mm, 5μ) column. Mobile phase composed of Acetonitrile ACN: 0.05M potassium dihydrogen orthophosphate buffer pH 4.2 and in the ratio of 75:25% v/v at a flow rate of 1.2  mL/min. Detection was carried out using a PDA detector at 220 nm.  The bioanalytical clopidogrel method was validated as per ICH guidelines.

Results: The selected chromatographic condition was found to efficiently separate clopidogrel bisulfate (RT-2.838 min). The calibration curve was linear over the concentration range 40-200 ng/mL in Wistar rat plasma with a correlation coefficient of 0.999, respectively.  The precision study revealed that the cumulative percentage variation was within the acceptable limit, and accuracy research showed the value of mean percent recovery between 99.72-99.83 %.

Conclusion: A simple, rapid, specific, accurate, and precise analytical method was developed and validated using Wister rat plasma. The technique was strictly validated according to the ICH guidelines. Acquired results demonstrate that the proposed strategy can be effortlessly and advantageously applied for routine analysis of clopidogrel in the Wister rat plasma.

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Published

22-11-2021

How to Cite

SURA, R. S., CVS, S., & RACHAMALLA, S. S. (2021). BIOANALYTICAL RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF CLOPIDOGREL BISULFATE IN WISTER RAT PLASMA AND ITS APPLICATION TO PHARMACOKINETIC STUDY. International Journal of Applied Pharmaceutics, 14(1). https://doi.org/10.22159/ijap.2022v14i1.43328

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