2015, Number 3
Stability of a formulation of 1mg/ml adrenaline injectable product for veterinary use
Mora ADA, García PCM, Montes de Oca PY, García BL, Martínez EV, Milanés FM, Gordo GY, Álvarez HY
Full text
Language: Spanish
References: 6
Page: 449-461
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ABSTRACT
Introduction: one mig/ml adrenaline injectable product is used in bovines, horses, caprine, ovines, swines, dogs and cats as direct myocardial stimulant in the anaphylactic shock, bronchial spasm because of its bronchodilating action, in local anesthesia to extend its action, local hemostatic agent in superficial hemorrhages, in urticaria and as conjunctival decongestive agent.Objective: to evaluate the high performance liquid chromatography analytical method applicable to the quality control and the stability study of the injectable and its time stability.
Methods: for quantification of the active principle in the final product, the separation was performed with a chromatographic columm Lichosorb RP-18(5µm) (250 x 4mm)and ultraviolect detection at 280nm, using a mobile phase of methanol-monobasic sodium phosphate 0.05 M, 1-sodium octanosulphonate and sodium edentate solution at pH 3.58 (3:17) and the quantification against a reference sample was made with the external standard method. The shelf life study was conducted for 12 months at room temperature and that of accelerated stability at 40°C for six months.
Results: the achieved results in the parameters analyzed in the evaluation of the method performance were within the set limits. The results of the shelf life stability study after 12 months indicated that the product keep the parameters that determine its quality during that time and no significant degradation of the product was observed in the accelerated studies.
Conclusions: the evaluation of the analytical method performance showed the reliability of the method. The expiry date was then set as one year under the stated conditions.
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