Stability of suxamethonium in pharmaceutical solution for injection by validated stability indicating chromatographic method.
STUDY 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% CONCLUSION Storage of suxamethonium solution for injection vials at ambient temperature (22degC 26degC) for 17 days demonstrated that at least 95% of original suxamethonium concentration remained stable.
Journal of clinical anesthesia