title: Stability of suxamethonium in pharmaceutical solution for injection by validated stability-indicating chromatographic method.
abstract: OBJECTIVE
  To assess the stability of pharmaceutical suxamethonium (succinylcholine) solution for injection by validated stability-indicating chromatographic method in vials stored at room temperature.
  
  
  METHODS
  The chromatographic assay was achieved by using a detector wavelength set at 218 nm, a C18 column, and an isocratic mobile phase (100% of water) at a flow rate of 0.6 mL/min for 5 minutes. The method was validated according to the International Conference on Harmonization guidelines with respect to the stability-indicating capacity of the method including linearity, limits of detection and quantitation, precision, accuracy, system suitability, robustness, and forced degradations.
  
  
  RESULTS
  Linearity was achieved in the concentration range of 5 to 40 mg/mL with a correlation coefficient higher than 0.999. The limits of detection and quantification were 0.8 and 0.9 mg/mL, respectively. The percentage relative standard deviation for intraday (1.3-1.7) and interday (0.1-2.0) precision was found to be less than 2.1%. Accuracy was assessed by the recovery test of suxamethonium from solution for injection (99.5%-101.2%).
  
  
  CONCLUSIONS
  Storage of suxamethonium solution for injection vials at ambient temperature (22°C-26°C) for 17 days demonstrated that at least 95% of original suxamethonium concentration remained stable.
authors.affiliation: Service Pharmacie, Hôpital Jean Verdier-AP-HP, Hôpitaux universitaires de Paris-Seine-Saint-Denis, Avenue du 14 juillet, 93140 Bondy, France.
authors.forename: William
authors.initials: W
authors.lastname: Beck
authors.affiliation: Service Pharmacie, Hôpital Jean Verdier-AP-HP, Hôpitaux universitaires de Paris-Seine-Saint-Denis, Avenue du 14 juillet, 93140 Bondy, France.
authors.forename: Sofiane
authors.initials: S
authors.lastname: Kabiche
authors.affiliation: Service Pharmacie, Hôpital Jean Verdier-AP-HP, Hôpitaux universitaires de Paris-Seine-Saint-Denis, Avenue du 14 juillet, 93140 Bondy, France.
authors.forename: Issa-Bella
authors.initials: IB
authors.lastname: Balde
authors.affiliation: Service Pharmacie, Hôpital Jean Verdier-AP-HP, Hôpitaux universitaires de Paris-Seine-Saint-Denis, Avenue du 14 juillet, 93140 Bondy, France.
authors.forename: Sandra
authors.initials: S
authors.lastname: Carret
authors.affiliation: Service Pharmacie, Hôpital Jean Verdier-AP-HP, Hôpitaux universitaires de Paris-Seine-Saint-Denis, Avenue du 14 juillet, 93140 Bondy, France.
authors.forename: Jean-Eudes
authors.initials: JE
authors.lastname: Fontan
authors.affiliation: Service Pharmacie, Hôpital Jean Verdier-AP-HP, Hôpitaux universitaires de Paris-Seine-Saint-Denis, Avenue du 14 juillet, 93140 Bondy, France.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Cisternino
authors.affiliation: Service Pharmacie, Hôpital Jean Verdier-AP-HP, Hôpitaux universitaires de Paris-Seine-Saint-Denis, Avenue du 14 juillet, 93140 Bondy, France. Electronic address: joel.schlatter@aphp.fr.
authors.forename: Joël
authors.initials: J
authors.lastname: Schlatter
mesh_terms: D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D009467:Neuromuscular Depolarizing Agents / Q000032:analysis* / Q000737:chemistry; D019999:Pharmaceutical Solutions; D015203:Reproducibility of Results; D013390:Succinylcholine / Q000032:analysis* / Q000737:chemistry
chemical_list: D009467:Neuromuscular Depolarizing Agents; D019999:Pharmaceutical Solutions; D013390:Succinylcholine
keywords: Forced degradation; Liquid chromatography; Solution for injection; Stability; Stability-indicating; Suxamethonium