DEVELOPPEMENT GALENIQUE ET ANALYTIQUE DU LATANOPROST COLLYRE A 0.005%

Abstract

Glaucoma is unquestionably a public health problem. OMS considers glaucoma the third leading cause of blindness (15%) in the world. The purpose of this work is to develop 0.005% Latanoprost eye drops used in this disease. For the control and monitoring of the stability of this product, the development of a method and its validation are envisaged. Three formulations were prepared at pH 7.2-6.8-6.4 and then monitored in stability over a three-month period at storage temperatures of: 5C°-25C°-30C°-40C°. The validated assay method is an isocratic HPLC technique. It uses a C18 column (Eurospher II, (150 x 4.6) mm, 5um) with a flow rate of 1ml/min and UV detection at 210 nm. The mobile phase consists of a mixture of (buffer pH 3/Acetonitrile): (40:60 V/V). All formulations exhibited degradation at temperatures above 25°C. The oxygen content in the preparation is a critical factor to monitor during the vial filling operation. The formulation at pH 7.2 is more stable than the formulation at pH 6.4 and 6.8. The storage temperature of this product is much better in the refrigerator than at room temperature.