RP-HPLC Method Development and Validation for Determination of Abemaciclib in Bulk Drug Substance and Pharmaceutical Dosage Forms

  • M. Maithani Department of Pharmaceutical Sciences, Hemvati Nandan Bahuguna Garhwal University, Srinagar, Pauri Garhwal, India
  • D.K. Dwivedi Multidisciplinary Research Unit, VCSG Institute of Medical Science and Research, Srinagar, Pauri Garhwal, India
DOI: https://doi.org/10.32553/jbpr.v12i5.1027

Abstract

A simple, economic, rapid and precise method for the quantification of Abemaciclib in bulk drug substance and pharmaceutical dosage forms was developed and validated using RP-HPLC. The chromatographic separation was achieved using Ascentis® C-18 HPLC column (250mm x 4.6mm i.d., particle size 5µ) with mobile phase containing 0.5% TFA: methanol: acetonitrile (35:45:20 v/v/v) with flow rate of 1.2mL/ min was used and effluents were monitored at 295nm. The retention time of Abemaciclib were found to be 3.72 min. The linearity was in the range of 6-42μg/mL. The limit of detection and limit of quantification were found to be 0.6 and 1.8 µg/mL, respectively. The % recoveries were found to be in the range of 99.65±0.77.

Keywords: Abemaciclib, Estimation, Bulk drug substance, Pharmaceutical dosage forms

Published
2023-10-28
How to Cite
Maithani, M., & Dwivedi, D. (2023). RP-HPLC Method Development and Validation for Determination of Abemaciclib in Bulk Drug Substance and Pharmaceutical Dosage Forms. Journal of Biomedical and Pharmaceutical Research, 12(5), 31-35. https://doi.org/10.32553/jbpr.v12i5.1027
Issue
Vol. 12 No. 5 (2023)
Section
Articles

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