Development and Validation of a HPLC-PDA Method to Quantification of Ketobemidone in Rat Plasma and its’ Application in Pharmacokinetic Study

Indian Journal of Pharmaceutical Education and Research

  • Shashipal Aitha1Department of Chemistry, School of Applied Science and Humanities, Vignan’s Foundation for Science, Technology and Research, Vadlamudi, Guntur, Andhra Pradesh, India.
  • Subramani Devaraju3Polymer Engineering Laboratory, Department of Chemistry, PSG Institute of Technology and Applied Research, Neelambur, Coimbatore, Tamil Nadu, INDIA.
  • Jayanti Naga Sri Rama Chandra Murthy2Discovery Analytical R and D Department, Aragen Life Sciences Pvt. Ltd., IDA Nacharam, Hyderabad, Telangana, INDIA.
  • Kiran Kumar Tatapudi2Discovery Analytical R and D Department, Aragen Life Sciences Pvt. Ltd., IDA Nacharam, Hyderabad, Telangana, INDIA.
  • Leela Prasad Geddada2Discovery Analytical R and D Department, Aragen Life Sciences Pvt. Ltd., IDA Nacharam, Hyderabad, Telangana, INDIA.
  • Tiruveedhula Somasekhar4Department of Freshmen Engineering, St. Martin’s Engineering College, Dhulapally, Hyderabad, Telangana, INDIA.
  • Hemambika Sadasivuni4Department of Freshmen Engineering, St. Martin’s Engineering College, Dhulapally, Hyderabad, Telangana, INDIA.
  • Muralidharan Kaliyaperumal2Discovery Analytical R and D Department, Aragen Life Sciences Pvt. Ltd., IDA Nacharam, Hyderabad, Telangana, INDIA.

Volume 59 Issue 2s Pages s740-s747

DOI: 10.5530/ijper.20256924

Abstract

Aim: Ketobemidone is an opioid drug that have been using against pain in various circumstances. The current research was aimed to develop and validate a HPLC-PDA method to estimate the ketobemidone in rat plasma. Materials and Methods: The ketobemidone in the biological matrices (rat plasma) was separated using solvent extraction method using methanol as extracting solvent. An isocratic mobile phase consisting of methanol-water-phosphate buffer at 40:60:0.01 % v/v/v and Kromasil C18 column were used for separation in Liquid Chromatography (LC). Results: The selected linearity range i.e., 0.10-25μg/mL was acceptable with r2 value 0.9998 as least square method. The determined Lower Limit of Quantification (LLOQ) is 0.10 μg/mL. The intermediate precision studies were performed within and between days; and the data obtained are within a significant range, i.e., %RSD <9.2 and the accuracy was within 10.0% of the relative error. Conclusion: The developed method to detect the ketobemidone was successfully validated and it was successfully applied on rat pharmacokinetic study.

Keywords

  • Hematocrit
  • HPLC-PDA bioassay
  • Ketobemidone
  • Rat plasma
  • Validation
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