Elaboración y control de calidad de la fórmula oficinal líquida de hidrato de cloral como agente sedante

Abstract

The aim of this research work was to elaborate and control the quality of the chloral hydrate liquid officinal formula as a sedative agent, by means of a non-experimental and qualitative study. The study population consisted of two batches of 250 mL of 10% Chloral Hydrate solution and each batch was filled in 50 mL bottles, in a total of 10 bottles. In order to conduct the research, four phases were followed: standard operating procedures (SOP) were developed for the officinal formula of 10% chloral hydrate, quality control of the raw material was carried out, the chloral hydrate formulation was prepared and the organoleptic, physical, chemical and microbiological parameters of the formulation were controlled. As results it was obtained that, four SOPs were elaborated on the control of the raw material, elaboration process of the formulation and quality control of the chloral hydrate officinal formulation; with regard to the quality control of the formulation, the sample was submitted under accelerated stability conditions, with a temperature of 30°C and humidity of 60%, determining the following values after 30 days: 98. 515 ± 0.368% of the active principle concentration, 3.570 ± 0.007 of pH, 1.2894 ± 0.0001 of density and the presence of visible particles was not observed. Regarding the microbiological analysis, there was an absence of aerobic bacteria, molds, yeasts and Escherichia coli. It was concluded that the chloral hydrate formulation complied with the quality parameters described in the United States pharmacopoeia and in the National Form, so it can be used for its sedative properties, especially in pediatric patients. It is recommended to follow the established protocols for a correct elaboration of officinal and magistral formulas.