<abstract xmlns="http://www.w3.org/1999/xhtml">A reverse-phase HPLC (RP-HPLC) method was developed for strontium ranelate using a full factorial, screening experimental design. The analytical procedure was validated according to international guidelines for linearity, selectivity, sensitivity, accuracy and precision. A separate experimental design was used to demonstrate the robustness of the method. Strontium ranelate was eluted at 4.4 minutes and showed no interference with the excipients used in the formulation, at 321 nm. The method is linear in the range of 20–320 μg mL−1 (<italic>R2</italic> = 0.99998). Recovery, tested in the range of 40–120 μg mL−1, was found to be 96.1–102.1 %. Intra-day and intermediate precision RSDs ranged from 1.0–1.4 and 1.2–1.4 %, resp. The limit of detection and limit of quantitation were 0.06 and 0.20 μg mL−1, resp. The proposed technique is fast, cost-effective, reliable and reproducible, and is proposed for the routine analysis of strontium ranelate.</abstract>

A reverse-phase HPLC (RP-HPLC) method was developed for strontium ranelate using a full factorial, screening experimental design. The analytical procedure was validated according to international guidelines for linearity, selectivity, sensitivity, accuracy and precision. A separate experimental design was used to demonstrate the robustness of the method. Strontium ranelate was eluted at 4.4 minutes and showed no interference with the excipients used in the formulation, at 321 nm. The method is linear in the range of 20–320 μg mL−1 (R2 = 0.99998). Recovery, tested in the range of 40–120 μg mL−1, was found to be 96.1–102.1 %. Intra-day and intermediate precision RSDs ranged from 1.0–1.4 and 1.2–1.4 %, resp. The limit of detection and limit of quantitation were 0.06 and 0.20 μg mL−1, resp. The proposed technique is fast, cost-effective, reliable and reproducible, and is proposed for the routine analysis of strontium ranelate.

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

Department of Biochemistry and Environmental Chemistry, Faculty of Pharmacy

Department of Toxicology and Biopharmacy, Faculty of Pharmacy

Department of Pharmaceutical Chemistry Faculty of Pharmacy

Acta Pharmaceutica

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

A reverse-phase HPLC (RP-HPLC) method was developed for strontium ranelate using a full factorial, screening experimental design. The analytical procedure was...

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

Published Online: Apr 26, 2018

Page range: 171 - 183

Accepted: Jan 18, 2018

DOI: https://doi.org/10.2478/acph-2018-0019

Keywords
strontium ranelate, HPLC, experimental design, full factorial design

© 2018 Béla Kovács et al., published by De Gruyter Open

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

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

Published Online: Apr 26, 2018

Page range: 171 - 183

Accepted: Jan 18, 2018

DOI: https://doi.org/10.2478/acph-2018-0019

Keywordsstrontium ranelate, HPLC, experimental design, full factorial design

© 2018 Béla Kovács et al., published by De Gruyter Open

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Keywords
strontium ranelate, HPLC, experimental design, full factorial design