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Acta Pharmaceutica, Vol. 68 No. 2, 2018.

Original scientific paper

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

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

BÉLA KOVÁCS ; Gedeon Richter Romania, 540306, Tîrgu Mureș, Romania; Department of Biochemistry and Environmental Chemistry, Faculty of Pharmacy, University of Medicine and Pharmacy, 540139, Tîrgu Mureș, Romania
LAJOS KRISTÓF KÁNTOR ; Gedeon Richter Romania, 540306, Tîrgu Mureș, Romania
MIRCEA DUMITRU CROITORU ; Department of Toxicology and Biopharmacy, Faculty of Pharmacy, University of Medicine and Pharmacy, 540139, Tîrgu Mureș, Romania
ÉVA KATALIN KELEMEN ; Gedeon Richter Romania, 540306, Tîrgu Mureș, Romania
MONA OBREJA ; Gedeon Richter Romania, 540306, Tîrgu Mureș, Romania
ELŐD ERNŐ NAGY ; Department of Biochemistry and Environmental Chemistry, Faculty of Pharmacy, University of Medicine and Pharmacy, 540139, Tîrgu Mureș, Romania
BLANKA SZÉKELY-SZENTMIKLÓSI ; Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Medicine and Pharmacy, 540139, Tîrgu Mureș, Romania
ÁRPÁD GYÉRESI ; Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Medicine and Pharmacy, 540139, Tîrgu Mureș, Romania

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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.

Keywords

strontium ranelate; HPLC; experimental design; full factorial design

Hrčak ID:

193565

URI

https://hrcak.srce.hr/193565

Publication date:

30.6.2018.

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