Development & validation of reversed phase HPLC method for quantification of water insoluble API

Pak J Pharm Sci. 2017 Sep;30(5(Supplementary)):2021-2024.

Abstract

In the present work a specific, accurate, precise, and reproducible UV-HPLC method was developed and validated for the analysis of Aceclofenac. This method involved elution of Aceclofenac in a mobile phase which is composed of buffer pH 6.8 (i.e. using 0.01N KH2PO4) and HPLC grade Acetonitrile (60:40). Separation of the analyte was achieved using HPLC isocratic pump attached to the UV-VIS detectorC18, guard column and C18 column. The injection volume was 20μL, detected at 274 nm; flow rate: 1mL/min. Standard calibration curve was measured and found linear from 0.1 to 40μg/ml. The validation parameters were measured according to FDA guidelines and successful results were obtained. The presented analytical method could be employed for pharmacokinetic studies.

Publication types

  • Validation Study

MeSH terms

  • Anti-Inflammatory Agents, Non-Steroidal / analysis*
  • Calibration
  • Chromatography, High Pressure Liquid* / standards
  • Chromatography, Reverse-Phase* / standards
  • Diclofenac / analogs & derivatives*
  • Diclofenac / analysis
  • Reference Standards
  • Reproducibility of Results
  • Solubility
  • Solvents / chemistry*
  • Spectrophotometry, Ultraviolet
  • Water / chemistry*

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Solvents
  • Water
  • Diclofenac
  • aceclofenac