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Reversed phase HPLC for strontium ranelate: Method development and validation applying experimental design.

Béla Kovács1,2, Lajos Kristóf Kántor1, Mircea Dumitru Croitoru3

  • 1Gedeon Richter Romania, 540306, Tîrgu Mureș, Romania.

Acta Pharmaceutica (Zagreb, Croatia)
|April 28, 2018
PubMed
Summary

A validated reverse-phase HPLC method accurately quantifies strontium ranelate. This reliable analytical technique is suitable for routine quality control of strontium ranelate formulations.

Keywords:
HPLCexperimental designfull factorial designstrontium ranelate

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Analysis

Background:

  • Strontium ranelate is a key pharmaceutical agent.
  • Accurate quantification is essential for quality control.

Purpose of the Study:

  • To develop and validate a robust analytical method for strontium ranelate.
  • To ensure the method is suitable for routine pharmaceutical analysis.

Main Methods:

  • Reverse-phase High-Performance Liquid Chromatography (RP-HPLC).
  • Full factorial experimental design for method development.
  • Validation according to international guidelines (ICH).

Main Results:

  • Strontium ranelate eluted at 4.4 minutes with no excipient interference at 321 nm.
  • Method demonstrated excellent linearity (R2=0.99998) from 20-320 μg mL-1.
  • High accuracy (96.1-102.1% recovery) and precision (RSDs 1.0-1.4%) were confirmed.

Conclusions:

  • The developed RP-HPLC method is fast, reliable, and cost-effective.
  • The method is validated for linearity, selectivity, sensitivity, accuracy, and precision.
  • Proposed for routine analysis of strontium ranelate in pharmaceutical formulations.