Acta Pharm. 68 (2018) 171-183
Original research paper
Reversed phase HPLC for strontium ranelate: Method development and validation applying experimental design
BÉLA KOVÁCS, LAJOS KRISTÓF KÁNTOR, MIRCEA DUMITRU CROITORU, ÉVA KATALIN
KELEMEN, MONA OBREJA, ELŐD ERNŐ NAGY, BLANKA SZÉKELY-SZENTMIKLÓSI and ÁRPÁD
GYÉRESI
kovacsbela89@gmail.com;
kovacs.bela@umftgm.ro
1 Gedeon
Richter Romania, 540306, Tîrgu Mureș,
Romania
2 Department
of Biochemistry and Environmental Chemistry, Faculty of Pharmacy, University of
Medicine and Pharmacy, 540139, Tîrgu Mureș, Romania
3 Department
of Toxicology and Biopharmacy, Faculty of Pharmacy,
University of Medicine and Pharmacy, Tîrgu Mureș, Romania
4 Department
of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Medicine and
Pharmacy, 540139, Tîrgu Mureș,
Romania
Accepted January 18, 2018
Published online February
19, 2018
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