Performance of the Analytical Method for the Study of the Real-time Stability of Succinylcholine-50 mg/ml as an Injectable Solution
Keywords:
injectable, succinylcholine, stability, chromatography, analytical technique performance.Abstract
Introduction: Stability study is among the basic criteria to be taken into account when developing a pharmaceutical product, in order to obtain safe information from it.
Objective: To evaluate the performance of the analytical method in the study of the real-time stability of succinylcholine-50 mg/ml as injectable solution.
Methods: The description and execution of the high-resolution liquid chromatography method for the quantification of the active pharmaceutical ingredient in the finished product was carried out, which was complemented with the organoleptic characteristics, sterility, bacterial endotoxins, pH and particle count; lots S19003, S19004 and S19005. The stability study was carried out at a frequency of three months during the first year, and subsequently every six months until 24 months were completed.
Results: In the description and implementation of the method, the chromatographic conditions for the assay were established; it was demonstrated that it is specific, precise and exact; adequate for the analysis of succinylcholine chloride as quality control and stability studies. 400 mL of 1g/L peptonized water was defined as the wash volume for the sterility assay (membrane filtration method) and 1:100 as the working dilution for the determination of bacterial endotoxins (Limulus amoebocyte lysate method). The behavior of pH (within the specification indices) was similar to the study under accelerated conditions, the tendency to decrease in titration, even within the specification values, corresponds to what has been described by other authors for this product. During the months of study all physicochemical and microbiological tests complied with the specifications established for the product.
Conclusions: The real-time stability study confirmed the shelf life of the finished product and the adequate storage conditions in the proposed container for its commercialization.
